| 1 |
NCT00326482 |
Recruiting |
Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy |
- Liver Disease
- Steatohepatitis
- HIV
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Presence of hepatic fibrosis on liver biopsy as measured histologically by stage
- Liver biopsy evidence of hepatic steatosis as measured by degree (0 to 4), character and location
- Liver biopsy evidence of hepatic inflammation by type and severity
- Correlation between histopathologic findings on liver biopsy and clinical, laboratory and radiologic parameters
|
180 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT00326482 |
060153
06-I-0153 |
|
May 15, 2006 |
|
|
May 17, 2006 |
May 21, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 2 |
NCT02015013 |
Recruiting |
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models |
- T-Lymphocytopenia, Idiopathic CD4-Positive
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
- to assess peripheral CD4 T cell and CD34 plus hematopoietic progenitor cell numbers and functions in ICL patients compared to controls following G-CSF and plerixafor administration.
|
40 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02015013 |
140020
14-I-0020 |
|
December 13, 2013 |
December 31, 2018 |
January 1, 2020 |
December 19, 2013 |
June 14, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 3 |
NCT03218592 |
Recruiting |
ENLIGHTEN: Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence |
|
- Drug: Maraviroc Pill
- Drug: Dolutegravir Pill
- Drug: Truvada Pill
|
Interventional
|
Phase 4 |
- University of North Carolina, Chapel Hill
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Hair Antiretroviral concentrations
- PBMC Antiretroviral Concentrations
- Plasma Antiretroviral Concentrations
- Whole Blood Antiretroviral Concentrations
|
36 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03218592 |
17-0546
1R01AI122319-01 |
ENLIGHTEN |
June 28, 2017 |
December 25, 2018 |
March 30, 2019 |
July 14, 2017 |
March 8, 2018 |
|
- Clinical and Translational Research Center, UNC Hospitals
Chapel Hill, North Carolina, United States
|
|
| 4 |
NCT00789009 |
Recruiting |
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection |
- HIV Infections
- AIDS
- Opportunistic Infections
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
|
600 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT00789009 |
090030
09-I-0030 |
|
December 1, 2008 |
|
|
November 11, 2008 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 5 |
NCT03324009 |
Not yet recruiting |
2-stage Cervical Cancer Screening in Botswana |
|
- Diagnostic Test: 2-stage screen
|
Interventional
|
Not Applicable |
- Beth Israel Deaconess Medical Center
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Performance of HPV-Pap screening algorithm
- Performance of HPV-VIA screening algorithm
|
300 |
Female |
25 Years and older (Adult, Older Adult) |
NCT03324009 |
2017P000388
5P30AI060354-14 |
|
May 2018 |
September 2018 |
December 2018 |
October 27, 2017 |
April 12, 2018 |
|
|
|
| 6 |
NCT01206920 |
Recruiting |
Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort |
|
|
Observational
|
|
- George Washington University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Following the health of those with HIV throughout the study
|
10000 |
All |
Child, Adult, Older Adult |
NCT01206920 |
071029
3U01AI069503-03S2 |
DC Cohort |
January 2011 |
November 2020 |
November 2020 |
September 22, 2010 |
March 2, 2018 |
|
- Kaiser Permanente
Washington, District of Columbia, United States - Unity Health Care
Washington, District of Columbia, United States - MetroHealth
Washington, District of Columbia, United States - (and 12 more...)
|
|
| 7 |
NCT00029445 |
Recruiting |
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors |
- Human Immunodeficiency Virus
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Studies of HIV-specific immunity
- Cohort Natural History Study
|
400 |
All |
18 Years and older (Adult, Older Adult) |
NCT00029445 |
020086
02-I-0086 |
|
January 4, 2002 |
|
|
January 14, 2002 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 8 |
NCT02788175 |
Recruiting |
Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption |
|
- Biological: Entyvio (Vedolizumab)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the safety and tolerability of vedolizumab in HIV-infected individuals prior to and following analytical treatment interruption (ATI).
- To evaluate the effect of vedolizumab administration on plasma viral rebound in HIV-infected individuals following ATI
|
40 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02788175 |
160118
16-I-0118 |
|
May 28, 2016 |
May 1, 2019 |
May 1, 2020 |
June 2, 2016 |
April 25, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 9 |
NCT02081638 |
Recruiting |
Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention Study |
|
- Drug: Aspirin 81 mg daily
- Drug: Atorvastatin 40 mg daily
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- The primary end point will be change of sCD14 from Month 3 to Month 12 in the two groups combined (EC and ART <50).
- Changes in soluble biomarkers (sCD14, IL-6, D-dimer, hsCRP, sCD163, sTF as well as other relevant markers of inflammation and coagulation) in EC and ART <50 groups treated with ASA or ATV, independently within each group and arm and with grou...
- Changes in T cell activation (measured by HLA-DR/CD38 co- expression), monocyte immune activation (measured by activated monocyte subsets expressing either CD14++CD16+ and CD14varCD16+ and markers of activation, CCR5 and TF, and migration, CCR2 ...
- Changes in MR imaging of carotids after 9 months of statin or ASA in each group and both groups combined.
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT02081638 |
140039
14-I-0039 |
|
March 5, 2014 |
March 1, 2019 |
March 2, 2020 |
March 7, 2014 |
June 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States - Hennipen County Medical Center
Minneapolis, Minnesota, United States
|
|
| 10 |
NCT03225118 |
Recruiting |
Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The time to plasma viral rebound in HIV-infected individuals undergoing analytical treatment interruption.
- The difference in frequency of HIV infected CD4+ and CD8+ T cells and the respective expression of immune exhaustion markers prior to and following ATI and after re-initiation of ART.
|
75 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03225118 |
170106
17-I-0106 |
|
July 17, 2017 |
July 1, 2020 |
January 1, 2025 |
July 21, 2017 |
June 1, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 11 |
NCT02840474 |
Recruiting |
Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to HIV-Infected Adults |
|
- Biological: VRC-HIVMAB080-00-AB (VRC01LS)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the safety and tolerability of VRC01LS administered at 40 mg/kg IV to HIV-1 infected viremic adults.
- To evaluate the pharmacokinetics of VRC01LS at 40 mg/kg IV.
- To evaluate the effect on CD4 count and viral load.
- To determine whether anti-drug antibody (ADA) to VRC01LS can bedetected.
|
20 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02840474 |
160147
16-I-0147 |
|
July 19, 2016 |
March 31, 2019 |
August 31, 2019 |
July 21, 2016 |
June 13, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 12 |
NCT01976715 |
Recruiting |
Study of People With HIV Infection Who Have High Viral Loads Despite Combination Antiretroviral Therapy |
- Acquired Immune Deficiency Syndrome Virus
- Acquired Immunodeficiency Syndrome Virus
- AIDS Virus
- (and 2 more...)
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The log viral load change over time during the study enrollment period
- Log viral load change during the inpatient directly observed therapy period
|
150 |
All |
14 Years to 100 Years (Child, Adult, Older Adult) |
NCT01976715 |
140009
14-I-0009 |
|
October 30, 2013 |
August 1, 2022 |
September 1, 2023 |
November 6, 2013 |
May 23, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 13 |
NCT00001281 |
Recruiting |
Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- Washington Hospital Center
- National Institutes of Health Clinical Center (CC)
|
NIH / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The purpose of this protocol is to provide a mechanism to obtain blood products and other biologic samples that will be used by NIH Intramural Investigators in studies of HIV and related diseases.
- To provide the opportunity to compare genomic and proteomic properties of specimens obtained from individuals with HIV and other immunodeficiencies with those of healthy volunteers.
|
2000 |
All |
18 Years and older (Adult, Older Adult) |
NCT00001281 |
910140
91-I-0140 |
|
May 21, 1991 |
|
|
November 4, 1999 |
March 29, 2018 |
|
- Washington Hospital Center
Washington, District of Columbia, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 14 |
NCT00001316 |
Recruiting |
Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- We also wish to investigate the HIV-specific B-cell and T-cell responses in the different subsets of cells in both peripheral blood, aswell as BM and LT of HIV-infected individuals.
- In addition, we wish to delineate the precise nature of the immunoregulatory mechanisms and altered homing patterns that contribute to the perturbations in the phenotype and functions of various lymphocyte subsets in peripheral blood versus the ...
- The purpose of this project is to determine the relative burden of human immunodeficiency virus (HIV) and/or associated changes in hematopoiesis and immune activation as well as HIV-specific responses in the various subsets of peripheral blood m...
|
400 |
All |
18 Years and older (Adult, Older Adult) |
NCT00001316 |
920125
92-I-0125 |
|
March 18, 1992 |
|
|
November 4, 1999 |
June 4, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 15 |
NCT01656564 |
Recruiting |
Clinical Outcomes in Persons With HIV Acquired Early in Life |
- HIV
- Childhood
- Natural History
- (and 2 more...)
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To explore the clinical outcomes and the impact of HIV infection and antiretroviral therapy on a cohort with HIV infection acquired in early life.
- To evaluate the prevalence and the extent of cardiac abnormalities in this population compared to healthy controls using non-invasive MR and CT imaging
- To identify long-term infectious and non-infectious complications of HIV and ART in this cohort
|
250 |
All |
10 Years and older (Child, Adult, Older Adult) |
NCT01656564 |
120157
12-I-0157 |
|
July 11, 2012 |
|
|
August 3, 2012 |
May 24, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 16 |
NCT00776412 |
Recruiting |
Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Obtain blood samples for further investigation into the correlation between markers of coagulation, including D-dimer, and markers of platelet function, inflammation, endothelial cell function, and clinical parameters in HIV-infected adults.
|
375 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT00776412 |
090013
09-I-0013 |
|
October 17, 2008 |
|
|
October 21, 2008 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 17 |
NCT03374202 |
Recruiting |
VRC 603: A Phase I Dose-Escalation Study of the Safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) Recombinant AAV Vector Expressing VRC07 HIV-1 Neutralizing Antibody in Antiretroviral -Treated, HIV-1 Infected Adults With Controlled Viremia. |
- HIV-1 Infected Adults With Controlled Viremia
|
- Genetic: VRC-HIVAAV070-00-GT (AAV8-VRC07)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the safety and tolerability of AAV8-VRC07 administered IM at 5x10(10) vg/kg, 5x10(11) vg/kg, or 2.5x10(12) vg/kg, to HIV-infected adults.
- To evaluate the pharmacokinetics of VRC07 at each dose level through 24 weeks after injection.
- To determine the AAV8-VRC07 dose that achieves at least 50 mcg/mL VRC07 concentration in serum.
- (and 2 more...)
|
25 |
All |
18 Years to 60 Years (Adult) |
NCT03374202 |
180030
18-I-0030 |
|
January 11, 2018 |
March 1, 2019 |
March 1, 2019 |
December 15, 2017 |
February 8, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 18 |
NCT03315962 |
Recruiting |
Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden |
|
- Behavioral: SPIRIT Intervention
- Combination Product: Single Pill Combination
- Other: Reduced Refill Frequency Intervention
|
Interventional
|
Not Applicable |
- University of California, San Francisco
- Makerere University
- National Institute of Allergy and Infectious Diseases (NIAID)
- Cipla Ltd.
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of HIV-infected adults initiating IPT within 12 months of being IPT-eligible in health facilities overseen by DHOs participating in the SEARCH-IPT Trial.
- Changes in DHO and providers' knowledge and attitudes related to IPT in both intervention and control arms over time, as measured by quantitative surveys and data from focus group discussions.
- Measures of social influence of DHOs on frontline providers own attitudes and practices in the intervention vs. control arms.
- (and 11 more...)
|
1800 |
All |
12 Months and older (Child, Adult, Older Adult) |
NCT03315962 |
16-21030
R01AI125000 |
SEARCH-IPT |
November 15, 2017 |
September 2021 |
September 2021 |
October 20, 2017 |
December 8, 2017 |
|
- Infectious Diseases Research Collaboration
Kampala, Uganda
|
|
| 19 |
NCT02968849 |
Recruiting |
Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa |
|
- Biological: ALVAC-HIV (vCP2438)
- Biological: Bivalent Subtype C gp120/MF59
- Biological: Placebo
|
Interventional
|
Phase 2
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Sanofi
- GlaxoSmithKline
- (and 2 more...)
|
NIH / Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Preventive vaccine efficacy (VE) of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 for the prevention of HIV infection
- Incidence of treatment-emergent reactogenicity
- Incidence of treatment-emergent adverse events
- (and 9 more...)
|
5400 |
All |
18 Years to 35 Years (Adult) |
NCT02968849 |
HVTN 702 |
HVTN702 |
October 2016 |
July 2021 |
July 2021 |
November 21, 2016 |
December 8, 2017 |
|
- Walter Sisulu University HIV Vaccine Research Unit CRS
Mthatha, Eastern Cape, South Africa - Kliptown Soweto CRS
Johannesburg, Gauteng, South Africa - Aurum Tembisa CRS
Johannesburg, Gauteng, South Africa - (and 11 more...)
|
|
| 20 |
NCT00039689 |
Recruiting |
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Immunologic and Virologic Assessments
|
750 |
All |
18 Years and older (Adult, Older Adult) |
NCT00039689 |
020202
02-I-0202 |
|
May 21, 2002 |
|
|
June 7, 2002 |
May 25, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 21 |
NCT03284710 |
Recruiting |
Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine |
|
- Biological: ALVAC-HIV (vCP2438)
- Biological: Bivalent Subtype C gp120/MF59
- Biological: Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension
- Biological: Bivalent Subtype C gp120
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- HIV Vaccine Trials Network
- Sanofi Pasteur, a Sanofi Company
- (and 2 more...)
|
NIH / Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Occurrence and level of vaccine-induced systemic IgG Ab binding to the 3 gp120 Env proteins contained in the vaccine regimen (ZM96, TV1.C, and 1086.C)
- Occurrence and level of vaccine-induced serum IgA Ab binding to the 3 gp120 Env proteins contained in the vaccine regimen (ZM96, TV1.C, and 1086.C)
- Frequency of severe local and systemic reactogenicity signs and symptoms (pain, tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia)
- (and 5 more...)
|
132 |
All |
18 Years to 40 Years (Adult) |
NCT03284710 |
HVTN 107 |
HVTN107 |
June 19, 2017 |
September 30, 2019 |
September 30, 2019 |
September 15, 2017 |
September 15, 2017 |
|
- Polana Canico Health Research and Training Center (CISPOC), National Institute of Health (INS) CRS
Maputo, Mozambique - Aurum Tembisa CRS
Johannesburg, Gauteng, South Africa - Soweto HVTN CRS
Johannesburg, Gauteng, South Africa - (and 3 more...)
|
|
| 22 |
NCT03122223 |
Recruiting |
Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants |
|
- Biological: ALVAC-HIV (vCP2438)
- Biological: Bivalent subtype C gp120/MF59
- Biological: Bivalent subtype C gp120/AS01(B)
- Biological: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- GlaxoSmithKline
- Sanofi Pasteur, a Sanofi Company
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of severe local and systemic reactogenicity signs and symptoms
- Frequency of AEs by body system, MedDRA preferred term, severity, and assessed relationship to study products
- Frequency of SAEs, AESIs, and new chronic conditions
- (and 8 more...)
|
320 |
All |
18 Years to 40 Years (Adult) |
NCT03122223 |
HVTN 120 |
HVTN 120 |
January 16, 2018 |
September 30, 2019 |
September 30, 2019 |
April 20, 2017 |
June 19, 2018 |
|
- Bridge HIV CRS
San Francisco, California, United States - The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States - Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States - (and 10 more...)
|
|
| 23 |
NCT02924389 |
Recruiting |
Dolutegravir in Reservoirs |
|
- Drug: dolutegravir
- Drug: Triumeq
- Drug: Truvada
|
Interventional
|
Not Applicable |
- Emory University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Maximum Dolutegravir Concentration in Blood Plasma
- Maximum Dolutegravir Concentration in Peripheral Blood Mononuclear Cells
- Maximum Dolutegravir Concentration in Rectal Tissue
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT02924389 |
IRB00089025
K23AI124913 |
|
September 2016 |
June 2020 |
June 2020 |
October 5, 2016 |
October 9, 2017 |
|
- Grady Health System
Atlanta, Georgia, United States - Ponce De Leon Center
Atlanta, Georgia, United States - Emory University
Atlanta, Georgia, United States
|
|
| 24 |
NCT02997969 |
Recruiting |
Safety and Immune Response to a Clade C DNA HIV Vaccine |
|
- Biological: DNA-HIV-PT123 vaccine
- Biological: Protein/MF59 vaccine
- Biological: Placebo
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- HIV Vaccine Trials Network
- IPPOX Foundation
- (and 2 more...)
|
NIH / Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Frequency of severe local and systemic reactogenicity signs and symptoms (pain, tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia)
- Frequency of adverse events (AEs)
- Frequency of serious adverse events (SAEs), adverse events of special interest (AESIs), and new chronic conditions (requiring medical intervention for 30 days or more)
- (and 7 more...)
|
132 |
All |
18 Years to 40 Years (Adult) |
NCT02997969 |
HVTN 111 |
HVTN111 |
May 2016 |
September 2017 |
September 2017 |
December 20, 2016 |
December 29, 2016 |
|
- Aurum Tembisa CRS
Johannesburg, Gauteng, South Africa - Isipingo CRS
Westville, Kwa Zulu Natal, South Africa - Aurum Institute Klerksdorp CRS
Klerksdorp, North West Province, South Africa - (and 2 more...)
|
|
| 25 |
NCT03382834 |
Recruiting |
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors |
|
- Drug: Tamoxifen
- Drug: Vorinostat
- Drug: Antiretroviral drugs
|
Interventional
|
Early Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequency of new Grade 3 or greater adverse events that are considered definitely, probably, or possibly related to study treatment
- Change in cell-associated HIV-1 RNA in resting CD4+ T cells from baseline
- Single copy HIV-1 RNA levels
- Total HIV-1 DNA levels
|
30 |
Female |
18 Years to 65 Years (Adult, Older Adult) |
NCT03382834 |
ACTG A5366
38190 |
|
April 26, 2018 |
November 15, 2019 |
November 15, 2019 |
December 26, 2017 |
May 30, 2018 |
|
- Alabama CRS
Birmingham, Alabama, United States - UCLA CARE Center CRS
Los Angeles, California, United States - Ucsf Hiv/Aids Crs
San Francisco, California, United States - (and 22 more...)
|
|
| 26 |
NCT03489109 |
Recruiting |
2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome |
- Human Immunodeficiency Virus
- Metabolic Syndrome
|
- Behavioral: Intermittent fasting
- Behavioral: Standard of Care
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in weight and insulin sensitivity as measured by HOMA-IR
- Tolerability of ICR
- Change in lipid levels, metabolic biomarkers, biomarkers of inflammation and immune activation, and mood.
- Change in body composition, including visceral adiposity abd hepatic steatosis.
|
100 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03489109 |
180075
18-I-0075 |
|
May 9, 2018 |
January 31, 2022 |
January 31, 2022 |
April 5, 2018 |
June 18, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 27 |
NCT02256631 |
Recruiting |
Evaluating the Safety and Pharmacokinetics of VRC01 and VRC01LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants |
|
- Biological: VRC01
- Biological: VRC01LS
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Death (number of participants)
- Frequency of Grade 3 or higher adverse events
- Frequency of VRC01- or VRC01LS-related Grade 3 or higher adverse events
- (and 5 more...)
|
118 |
All |
Child, Adult, Older Adult |
NCT02256631 |
IMPAACT P1112
11903 |
|
April 2015 |
December 2018 |
|
October 3, 2014 |
December 6, 2017 |
|
- University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
La Jolla, California, United States - Usc La Nichd Crs
Los Angeles, California, United States - David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States - (and 17 more...)
|
|
| 28 |
NCT03092505 |
Recruiting |
Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA) |
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Compare the prevalence of herpetic disease, demonstrated by viral shedding of HSV-1 and 2 in the vaginal secretions of HIV-positive women prior to and 4 and 8 weeks after ART initiation.
- To estimate the associations of viral shedding or clinical herpetic disease post-ART at weeks 4 or 8 with concurrent and baselinemeasurement of systemic inflammation (IL-6, CRP, TNF or sCD14).
- To estimate the associations of viral shedding or clinical herpetic disease post-ART at weeks 4 or 8 with concurrent and baselinemeasurements of cellular activation (CD4 and CD8 T cells expressing HLA-DR/CD38).
- To estimate the associations of viral shedding or clinical herpetic disease in genital area post-ART at weeks 4 or 8 with concurrent and baseline measurements of cytokine levels in vaginal secretions.
|
400 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03092505 |
170072
17-I-0072 |
|
June 15, 2018 |
February 1, 2021 |
February 1, 2021 |
March 28, 2017 |
June 20, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 29 |
NCT02344290 |
Recruiting |
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults |
- HIV Infections
- Cardiovascular Diseases
|
- Drug: Pitavastatin
- Drug: Placebo
|
Interventional
|
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Heart, Lung, and Blood Institute (NHLBI)
- Kowa Pharmaceuticals America, Inc.
- (and 2 more...)
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Time to the first event of a composite of major cardiovascular events
- Time to the first of each individual component of the primary endpoint
- Time to death (all-cause mortality)
- (and 10 more...)
|
7500 |
All |
40 Years to 75 Years (Adult, Older Adult) |
NCT02344290 |
A5332
11960
1U01HL123339-01
1U01HL123336-01 |
REPRIEVE |
March 2015 |
April 1, 2022 |
April 1, 2022 |
January 22, 2015 |
May 30, 2018 |
|
- Alabama CRS
Birmingham, Alabama, United States - University of Arizona CRS
Tucson, Arizona, United States - University of Southern California CRS
Los Angeles, California, United States - (and 129 more...)
|
|
| 30 |
NCT03386578 |
Not yet recruiting |
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum |
|
- Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
- Behavioral: Behavioral HIV risk reduction package
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of participants with steady state TFV-DP concentrations in the PK Component
- TFV-DP drug concentration levels in participants in the PrEP Comparison Component
- Frequency of maternal Grade 3 or higher adverse events in participants in the PrEP Comparison Component
- (and 8 more...)
|
390 |
Female |
16 Years to 24 Years (Child, Adult) |
NCT03386578 |
IMPAACT 2009
30020 |
|
July 2018 |
July 2021 |
July 2021 |
December 29, 2017 |
March 19, 2018 |
|
|
|
| 31 |
NCT03164564 |
Recruiting |
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women |
|
- Drug: Oral CAB
- Drug: Oral TDF/FTC
- Drug: Placebo for oral CAB
- (and 3 more...)
|
Interventional
|
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of documented incident HIV infections in Steps 1 and 2
- Number of Grade 3 or higher clinical and laboratory adverse events (AEs)
- Number of documented incident HIV infections in participants in subgroups broken down by baseline age
- (and 6 more...)
|
3200 |
Female |
18 Years to 45 Years (Adult) |
NCT03164564 |
HPTN 084
38070 |
|
November 7, 2017 |
May 2022 |
May 2022 |
May 23, 2017 |
June 15, 2018 |
|
- Gaborone CRS
Gaborone, South-East District, Botswana - Kisumu Crs
Kisumu, Nyanza, Kenya - Malawi CRS
Lilongwe, Central, Malawi - (and 12 more...)
|
|
| 32 |
NCT02915016 |
Recruiting |
Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults |
|
- Biological: DNA-HIV-PT123 vaccine
- Biological: Bivalent Subtype C gp120/MF59 vaccine
- Biological: Bivalent Subtype C gp120/AS01B vaccine
- Biological: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of severe local and systemic reactogenicity signs and symptoms (pain, tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia)
- Frequency of adverse events (AEs)
- Frequency of serious adverse events (SAEs), adverse events of special interest (AESIs), and new chronic conditions (requiring medical intervention for 30 days or more)
- (and 7 more...)
|
334 |
All |
18 Years to 40 Years (Adult) |
NCT02915016 |
HVTN 108
12007 |
|
December 2016 |
October 2018 |
|
September 26, 2016 |
February 2, 2018 |
|
- Alabama CRS
Birmingham, Alabama, United States - Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States - Fenway Health (FH) CRS
Boston, Massachusetts, United States - (and 14 more...)
|
|
| 33 |
NCT02568215 |
Recruiting |
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women |
|
- Biological: VRC01
- Biological: Placebo for VRC01
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of participants with local and systemic reactogenicity signs and symptoms
- Number of participants with adverse events (AEs)
- Number of participants with severe adverse events (SAEs)
- (and 6 more...)
|
1900 |
Female |
18 Years to 50 Years (Adult) |
NCT02568215 |
HVTN 703/HPTN 081
12045 |
|
May 2016 |
December 2021 |
|
October 5, 2015 |
March 29, 2018 |
|
- Gaborone CRS
Gaborone, South-East District, Botswana - Kisumu Crs
Kisumu, Nyanza, Kenya - Blantyre CRS
Blantyre, Southern Region, Malawi - (and 18 more...)
|
|
| 34 |
NCT02716675 |
Recruiting |
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men |
|
- Biological: VRC01
- Biological: Placebo for VRC01
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of participants with local and systemic reactogenicity signs and symptoms
- Number of participants with adverse events (AEs)
- Number of participants with severe adverse events (SAEs)
- (and 6 more...)
|
2700 |
Male |
18 Years to 50 Years (Adult) |
NCT02716675 |
HVTN 704/HPTN 085
30095 |
|
March 2016 |
February 2022 |
|
March 23, 2016 |
March 29, 2018 |
|
- Alabama CRS
Birmingham, Alabama, United States - UCLA Vine Street Clinic CRS
Los Angeles, California, United States - Bridge HIV CRS
San Francisco, California, United States - (and 23 more...)
|
|
| 35 |
NCT03382418 |
Recruiting |
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States |
|
- Biological: gp145 C.6980 Vaccine
- Biological: Placebo
- Biological: Aluminum Hydroxide Adjuvant
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of severe local reactogenicity signs/symptoms
- Frequency of severe systemic reactogenicity signs/symptoms
- Frequency of adverse events (AEs)
- (and 7 more...)
|
45 |
All |
18 Years to 50 Years (Adult) |
NCT03382418 |
HVTN 122
12030 |
|
December 27, 2017 |
May 15, 2019 |
May 15, 2019 |
December 22, 2017 |
January 31, 2018 |
|
- Columbia P&S CRS
New York, New York, United States - New York Blood Center CRS
New York, New York, United States - Penn Prevention CRS
Philadelphia, Pennsylvania, United States
|
|
| 36 |
NCT03181789 |
Recruiting |
Evaluating the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA by Intramuscular Electroporation, in Healthy, HIV-Uninfected Adults |
|
- Biological: p24CE1/2 pDNA Vaccine
- Biological: p55^gag pDNA Vaccine
- Biological: IL-12 pDNA Adjuvant
- (and 2 more...)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of local injection/electroporation (EP) site reactogenicity signs/symptoms
- Severity of local injection/EP site reactogenicity signs/symptoms
- Frequency of systemic reactogenicity signs/symptoms
- (and 11 more...)
|
56 |
All |
18 Years to 50 Years (Adult) |
NCT03181789 |
HVTN 119
12061 |
HVTN 119 |
October 18, 2017 |
October 2019 |
October 2019 |
June 9, 2017 |
March 20, 2018 |
|
- Bridge HIV CRS
San Francisco, California, United States - The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States - Case Clinical Research Site
Cleveland, Ohio, United States
|
|
| 37 |
NCT03048422 |
Recruiting |
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants |
|
- Drug: Dolutegravir
- Drug: Emtricitabine/tenofovir alafenamide
- Drug: Emtricitabine/tenofovir disoproxil fumarate
- Drug: Efavirenz/emtricitabine/tenofovir disoproxil fumarate
|
Interventional
|
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of mothers with HIV-1 RNA less than 200 copies/mL at delivery
- Proportion of mothers with an adverse pregnancy outcome of spontaneous abortion (at <20 weeks gestation), fetal death (at ≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile)
- Cumulative proportion of mothers with grade 3 or higher adverse events, including events resulting in death due to any cause
- (and 15 more...)
|
639 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03048422 |
IMPAACT 2010
30129 |
VESTED |
December 12, 2017 |
November 2020 |
November 2020 |
February 9, 2017 |
June 5, 2018 |
|
- Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States - Pediatric Perinatal HIV Clinical Trials Unit CRS
Miami, Florida, United States - Gaborone CRS
Gaborone, South-East District, Botswana - (and 18 more...)
|
|
| 38 |
NCT02720094 |
Recruiting |
Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men |
|
- Drug: Cabotegravir tablets
- Drug: TDF/FTC tablets
- Drug: TDF/FTC placebo tablets
- (and 3 more...)
|
Interventional
|
Phase 2
Phase 3 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- ViiV Healthcare
- Gilead Sciences
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of documented incident HIV infections in Steps 1 and 2
- Number of Grade 2 or higher clinical and laboratory adverse events
- Number of documented incident HIV infections in Step 2
- (and 7 more...)
|
4500 |
All |
18 Years and older (Adult, Older Adult) |
NCT02720094 |
HPTN 083
20725 |
|
December 2016 |
September 30, 2021 |
September 30, 2021 |
March 25, 2016 |
May 15, 2018 |
|
- Alabama CRS
Birmingham, Alabama, United States - UCLA Vine Street Clinic CRS
Los Angeles, California, United States - UCLA CARE Center CRS
Los Angeles, California, United States - (and 42 more...)
|
|
| 39 |
NCT03500315 |
Recruiting |
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients |
|
|
Interventional
|
Not Applicable |
- Johns Hopkins University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
- Pre-transplant mortality
- Graft failure
- (and 22 more...)
|
360 |
All |
18 Years and older (Adult, Older Adult) |
NCT03500315 |
IRB00141138
U01AI134591 |
|
April 19, 2018 |
August 1, 2021 |
August 1, 2022 |
April 17, 2018 |
May 22, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of California, Los Angeles
Los Angeles, California, United States - University of California, San Francisco
San Francisco, California, United States - (and 16 more...)
|
|
| 40 |
NCT02741323 |
Recruiting |
Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients |
- HIV Infections
- Kidney Diseases
|
- Drug: Maraviroc
- Drug: Placebo
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Measured glomerular filtration rate by iohexol clearance
- Number of participants with graft loss, Grade 3 or greater toxicities, and/or permanent treatment discontinuations
- Proportion of participants with estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m^2
- (and 23 more...)
|
130 |
All |
18 Years and older (Adult, Older Adult) |
NCT02741323 |
HIVTR-CCR5
20730 |
|
January 1, 2017 |
April 2021 |
|
April 18, 2016 |
February 12, 2018 |
|
- UAB HIVTR-CCR5 Non-Network CRS
Birmingham, Alabama, United States - UCLA HIVTR-CCR5 Non-Network CRS
Los Angeles, California, United States - UCSF HIVTR-CCR5 Non-network CRS
San Francisco, California, United States - (and 7 more...)
|
|
| 41 |
NCT03263195 |
Recruiting |
Prospective Cohort Study of HIV and Zika in Infants and Pregnancy |
- HIV
- Zika Virus
- Pregnant Women
|
|
Observational
|
|
- Westat
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Enrollment (150 HIV-infected and 50 HIV-uninfected pregnant women within one year, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy).
- Viral suppression (in HIV-infected women with ZIKV co-infection compared to those without ZIKV co-infection during pregnancy and at the time of delivery).
- Incidence of ZIKV infection (among pregnant women with HIV infection compared to those without HIV infection).
- (and 8 more...)
|
3800 |
Female |
15 Years and older (Child, Adult, Older Adult) |
NCT03263195 |
HIV-ZIP |
HIV ZIP |
August 23, 2017 |
July 2024 |
July 2024 |
August 28, 2017 |
February 7, 2018 |
|
- University of Miami Pediatric/Prenatal HIV/AIDS
Miami, Florida, United States - South Florida Children's Diagnostic and Treatment Center, Inc.
Pompano Beach, Florida, United States - Bronx-Lebanon Hospital Center NICHD CRS
Bronx, New York, United States - (and 7 more...)
|
|
| 42 |
NCT03505060 |
Not yet recruiting |
Evaluating the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-Administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adults |
|
- Biological: DNA CON-S env
- Biological: IHV01
- Biological: Placebo
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of local and systemic reactogenicity signs and symptoms
- Distribution of values of laboratory measures of safety
- Frequency of adverse events (AEs)
- (and 7 more...)
|
24 |
All |
18 Years to 50 Years (Adult) |
NCT03505060 |
HVTN 125
30015 |
|
January 1, 2019 |
May 2019 |
November 11, 2019 |
April 23, 2018 |
May 14, 2018 |
|
- Bridge HIV CRS
San Francisco, California, United States
|
|
| 43 |
NCT02591420 |
Recruiting |
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection |
|
- Biological: VRC01
- Biological: Placebo for VRC01
- Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of grade 3 or greater mAb-related reactogenicity and mAb-related adverse events (AEs)
- Plasma viral load change from Day 0 to Day 7
- Time to virologic suppression (less than 50 copies/ml) in plasma
- (and 9 more...)
|
24 |
All |
18 Years to 50 Years (Adult) |
NCT02591420 |
RV 398
12002
WRAIR 2166 |
|
April 2016 |
April 2018 |
|
October 29, 2015 |
February 12, 2018 |
|
- Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
Kericho, Kenya - National Institute for Medical Research (NIMR)-Mbeya Medical Research Center (MMRC) Non-Network CRS
Mbeya, Tanzania - ECHO Center Non-Network CRS
Chonburi, Thailand - Makerere University Walter Reed Project (MUWRP)
Kampala, Uganda
|
|
| 44 |
NCT02797093 |
Recruiting |
Impact of ART Adherence on HIV Persistence and Inflammation |
- Human Immunodeficiency Virus
|
|
Observational
|
|
- University of Colorado, Denver
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Observational Model: Ecologic or Community
- Time Perspective: Prospective
|
- Level of tenofovir diphosphate in dried blood spots associated with the size of the HIV reservoir measured by the amount of CA-RNA and CA-DNA in PBMCs.
- Level of self-reported adherence (4-day, 30-day and 3-months using a visual analog scale) associated with the size of the HIV reservoir measured by CA-RNA and CA-DNA in PBMCs.
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02797093 |
15-2309
1R21AI124859-01 |
|
January 2016 |
March 2019 |
March 2019 |
June 13, 2016 |
May 23, 2018 |
|
- University of Colorado, Denver
Aurora, Colorado, United States
|
|
| 45 |
NCT01751568 |
Recruiting |
Evaluating the Safety, Tolerance, and Pharmacokinetics of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in Infants and Children Infected With HIV and TB |
- HIV Infections
- Tuberculosis
|
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Termination from treatment due to adverse events of greater than or equal to Grade 3 deemed at least possibly related to raltegravir
- Death, Grade 4 life-threatening adverse events deemed at least possibly related to raltegravir
- Grade 4 non-life threatening adverse events deemed as probably or definitely related to raltegravir
- (and 4 more...)
|
108 |
All |
up to 11 Years (Child) |
NCT01751568 |
P1101
11831
IMPAACT P1101 |
|
May 2014 |
May 2019 |
|
December 18, 2012 |
May 9, 2017 |
|
- Soweto IMPAACT CRS
Johannesburg, Gauteng, South Africa - Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, South Africa - Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
Cape Town, Western Cape Province, South Africa - Fam-Cru Crs
Tygerberg, Western Cape Province, South Africa
|
|
| 46 |
NCT03208231 |
Recruiting |
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in HIV-Infected Infants Receiving Combination Antiretroviral Therapy |
|
- Biological: VRC01
- Drug: Combination Antiretroviral Therapy (cART)
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequency of Grade 3 or higher adverse events (AEs)
- Change of HIV-1 DNA concentration in peripheral blood mononuclear cells (PBMCs) from baseline (Week 0) to Week 14
- Pharmacokinetic (PK) parameters of VRC01 in the plasma at Weeks 2, 6, 10, 14, and 16 (Arm 1 only)
|
68 |
All |
up to 12 Weeks (Child) |
NCT03208231 |
IMPAACT 2008
20735 |
|
May 8, 2018 |
September 1, 2020 |
June 1, 2021 |
July 5, 2017 |
June 5, 2018 |
|
- David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States - South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States - Gaborone CRS
Gaborone, South-East District, Botswana - (and 4 more...)
|
|
| 47 |
NCT03409276 |
Recruiting |
Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults |
|
- Biological: env (A,B,C,A/E)/gag (C) DNA Vaccine
- Biological: gp120 (A,B,C,A/E) Protein Vaccine
- Biological: Placebo
- Biological: GLA-SE adjuvant
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency of local injection site (including DTH) reactogenicity signs and symptoms
- Frequency of systemic reactogenicity signs and symptoms
- Frequency of adverse events (AEs)
- (and 8 more...)
|
60 |
All |
18 Years to 50 Years (Adult) |
NCT03409276 |
HVTN 124
38302 |
|
March 16, 2018 |
February 2020 |
October 2020 |
January 24, 2018 |
June 5, 2018 |
|
- Alabama CRS
Birmingham, Alabama, United States - Fenway Health (FH) CRS
Boston, Massachusetts, United States - Case Clinical Research Site
Cleveland, Ohio, United States - Penn Prevention CRS
Philadelphia, Pennsylvania, United States
|
|
| 48 |
NCT03220724 |
Recruiting |
Evaluating the Safety and Immunogenicity of EnvSeq-1 Envs Adjuvanted With GLA-SE, Administered Alone or With DNA Mosaic-Tre Env, in Healthy, HIV-Uninfected Adults |
|
- Biological: CH505TF
- Biological: CH505w53
- Biological: CH505w78
- (and 4 more...)
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Part A: Frequency of local reactogenicity signs and symptoms
- Part A: Frequency of systemic reactogenicity signs and symptoms
- Part A: Frequency of adverse events (AEs)
- (and 17 more...)
|
132 |
All |
18 Years to 50 Years (Adult) |
NCT03220724 |
HVTN 115
12042 |
|
August 22, 2017 |
December 2020 |
December 2020 |
July 18, 2017 |
November 8, 2017 |
|
- Alabama CRS
Birmingham, Alabama, United States - Columbia P&S CRS
New York, New York, United States - New York Blood Center CRS
New York, New York, United States - University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
|
|
| 49 |
NCT01302847 |
Recruiting |
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents |
|
- Drug: Dolutegravir (DTG) film-coated tablets
- Drug: DTG granules for suspension
- Drug: DTG dispersible tablets
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Toxicity
- Pharmacokinetics as assessed by the area under the curve (AUC)
- Plasma HIV-1 RNA less than 400 copies/ml
- (and 5 more...)
|
160 |
All |
up to 17 Years (Child) |
NCT01302847 |
P1093
11773
2010-020988-20
IMPAACT P1093 |
|
March 2011 |
June 30, 2020 |
June 30, 2025 |
February 24, 2011 |
May 25, 2018 |
|
- University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
La Jolla, California, United States - Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States - Usc La Nichd Crs
Los Angeles, California, United States - (and 55 more...)
|
|
| 50 |
NCT03497676 |
Not yet recruiting |
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents |
|
- Drug: Oral Cabotegravir (CAB)
- Drug: Oral Rilpivirine (RPV)
- Drug: Long-Acting Injectable Cabotegravir (CAB LA)
- (and 2 more...)
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants who had Grade 3 or higher adverse events (Cohort 1)
- Number of participants who had Grade 3 or higher adverse events assessed as related to study product/s (Cohort 1)
- Number of participants who had serious adverse events meeting International Conference on Harmonisation (ICH) criteria assessed as related to study product/s (Cohort 1)
- (and 12 more...)
|
155 |
All |
12 Years to 17 Years (Child) |
NCT03497676 |
IMPAACT 2017
30070 |
MOCHA |
July 2018 |
April 2021 |
August 2023 |
April 13, 2018 |
April 13, 2018 |
|
|
|
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