1 |
NCT01576731 |
Completed |
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP) |
|
- Drug: Tenofovir, Emtricitabine, Lopinavir/r
- Drug: Tenofovir, Emtricitabine, Raltegravir
|
Interventional |
Phase 4 |
- Hospital Clinic of Barcelona
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Proportion of patients dropping out before the 28 days of postexposure prophylaxis
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT01576731 |
2011-003799-35 |
RAL-PEP |
July 2012 |
July 2014 |
July 2014 |
April 12, 2012 |
April 1, 2015 |
|
- Hospital Clínic of Barcelona
Barcelona, Spain
|
2 |
NCT01583439 |
Terminated |
The Mochudi Prevention Project ART Protocol |
|
- Drug: highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine
|
Interventional |
Not Applicable |
- Harvard School of Public Health
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART
- The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up
- The proportion of participants with excellent adherence (defined as participant self-report of taking at least 95% of doses of antiretrovirals during the previous 4 days, on all assessments) by the end of follow-up
- (and 5 more...)
|
11 |
All |
16 Years to 64 Years (Child, Adult) |
NCT01583439 |
BHP041 R01AI083036 |
|
September 2012 |
February 2013 |
September 2013 |
April 24, 2012 |
March 19, 2015 |
|
- Deborah Retief Memorial Hospital
Mochudi, Botswana
|
3 |
NCT01578889 |
Completed |
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults |
|
- Biological: HIV-MAG vaccine
- Biological: IL-12 pDNA adjuvant
- Biological: VSV HIV gag vaccine
- (and 2 more...)
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Frequency and severity of local injection/EP site reactogenicity signs and symptoms
- Frequency and severity of systemic reactogenicity signs and symptoms
- Magnitude of local injection/EP site pain as measured by a visual analog scale
- (and 8 more...)
|
100 |
All |
18 Years to 50 Years (Adult) |
NCT01578889 |
HVTN 087 11673 |
|
May 2012 |
September 2014 |
October 2016 |
April 17, 2012 |
December 13, 2016 |
|
- 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 - (and 2 more...)
|
4 |
NCT01565850 |
Completed Has Results |
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults |
- Acquired Immunodeficiency Syndrome
- HIV Infections
|
- Drug: D/C/F/TAF
- Drug: DRV
- Drug: COBI
- (and 5 more...)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
- Change From Baseline in HIV-1 RNA at Week 24
- (and 3 more...)
|
153 |
All |
18 Years and older (Adult, Senior) |
NCT01565850 |
GS-US-299-0102 |
|
April 2012 |
January 2013 |
February 2014 |
March 29, 2012 |
April 11, 2016 |
April 11, 2016 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - AHF Research Center
Beverly Hills, California, United States - Kaiser Permanente
Los Angeles, California, United States - (and 41 more...)
|
5 |
NCT01579695 |
Recruiting |
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA® |
|
- Drug: Tesamorelin for injection
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
- Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events
|
3190 |
All |
18 Years and older (Adult, Senior) |
NCT01579695 |
EMR200147-501 |
|
February 2013 |
December 2029 |
March 2030 |
April 18, 2012 |
August 15, 2016 |
|
- Franco Felizarta, MD
Bakersfield, California, United States - Pacific Coast Medical Group
Fountain Valley, California, United States - University of California CARE Clinic, Los Angeles
Los Angeles, California, United States - (and 28 more...)
|
6 |
NCT01571960 |
Completed |
Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive Adults |
|
- Biological: GEO-D03 DNA vaccine
- Biological: MVA/HIV62B (MVA62B) vaccine
- Biological: Placebo for GEO-D03 DNA
- Biological: Placebo for MVA62B:
|
Interventional |
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- GeoVax, Inc.
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Frequency and severity of local injection site reactogenicity signs and symptoms
- Frequency and severity of systemic reactogenicity signs and symptoms and maximum severity of systemic symptoms
- Distribution of values of safety laboratory measures: complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and creatinine
- (and 11 more...)
|
48 |
All |
18 Years to 50 Years (Adult) |
NCT01571960 |
HVTN 094 11827 |
|
April 2012 |
August 2014 |
January 2016 |
April 5, 2012 |
January 24, 2017 |
|
- Alabama CRS
Birmingham, Alabama, United States - Bridge HIV CRS
San Francisco, California, United States - Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States - University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
|
7 |
NCT01561755 |
Terminated Has Results |
A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy |
- HIV-associated Myelopathy
|
- Drug: Intravenous Immunoglobulin
- Drug: Placebo
|
Interventional |
Phase 4 |
- David M. Simpson
- CSL Behring
- Icahn School of Medicine at Mount Sinai
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Strength Scores
- Walking Test
- Urinary Function
- (and 4 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT01561755 |
GCO 10-1108 HS#: 11-02029 |
|
February 2012 |
September 2016 |
September 2016 |
March 23, 2012 |
April 13, 2018 |
April 13, 2018 |
- Icahn School of Medicine at Mount Sinai
New York, New York, United States
|
8 |
NCT01581853 |
Completed |
Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily |
|
- Drug: Lopinavir/ritonavir 800 mg / 200mg
|
Interventional |
Phase 4 |
- Daniel Podzamczer
- Hospital Universitari de Bellvitge
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- plasma viral load <40 copies/mL
- Stability in the plasma levels of Lopinavir/ritonavir during all study visits
- Tolerability
- (and 3 more...)
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01581853 |
KMON 2011-005981-39 |
|
May 2012 |
July 2014 |
July 2014 |
April 20, 2012 |
October 6, 2016 |
|
- Hospital del Mar
Bercelona, Barcelona, Spain - Hospital Universitary de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain
|
9 |
NCT01562886 |
Completed Has Results |
The Rilpivirine Cerebrospinal-fluid (CSF) Study |
|
|
Interventional |
Phase 1 |
- Imperial College London
- Janssen-Cilag Ltd.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- CSF:Plasma Ratio of Rilpivirine Levels
- Number of Subjects With HIV Viral Load Above 50 Copies Per mL
|
14 |
Male |
18 Years and older (Adult, Senior) |
NCT01562886 |
278_CSF 2011-004026-98 |
|
March 2012 |
November 2012 |
February 2013 |
March 26, 2012 |
June 19, 2014 |
June 19, 2014 |
- Imperial College Healthcare NHS Trust
London, United Kingdom
|
10 |
NCT01580657 |
Completed |
Experimental Analysis of HIV Risk Assessment Reactivity in South African Clinics |
- HIV Prevention and Assessment Reactivity
|
- Behavioral: Detailed baseline interview, enhanced HIV intervention
- Behavioral: General baseline interview, enhanced HIV intervention
- Behavioral: No baseline interview, enhanced HIV intervention
- (and 3 more...)
|
Interventional |
Not Applicable |
- Medical College of Wisconsin
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
|
- Reactivity assessment
- Risk Behavior Frequency
|
1728 |
All |
18 Years and older (Adult, Senior) |
NCT01580657 |
PRO00005529 5R01MH077515-04 |
|
September 2006 |
October 2010 |
October 2010 |
April 19, 2012 |
April 19, 2012 |
|
- Site B Youth Clinic
Khayelitsha, South Africa
|
11 |
NCT01568892 |
Unknown † Has Results |
Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir |
- Infection, Human Immunodeficiency Virus
|
- Drug: dolutegravir 50 mg twice daily
- Drug: dolutegravir placebo twice daily
- Drug: Open-label dolutegravir 50mg twice daily
|
Interventional |
Phase 3 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8
- Absolute Values in Plasma HIV-1 RNA Over Time
- Mean Change From Baseline in Plasma HIV-1 RNA Over Time
- (and 15 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT01568892 |
116529 |
VIKING-4 |
April 2012 |
October 2012 |
June 2015 |
April 2, 2012 |
February 19, 2014 |
February 19, 2014 |
- GSK Investigational Site
Little Rock, Arkansas, United States - GSK Investigational Site
Bakersfield, California, United States - GSK Investigational Site
Beverly Hills, California, United States - (and 22 more...)
|
12 |
NCT01563328 |
Completed |
A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697). |
- Infection, Human Immunodeficiency Virus
|
- Drug: DTG
- Drug: BCV
- Drug: TVR
|
Interventional |
Phase 1 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Plasma steady-state DTG PK parameters AUC(0-τ), Cmax, Cmin, and Cτ
- Safety and tolerability parameters as assessed by change from baseline in vital signs n(BP and HR), number of subjects with adverse events and toxicity grading of clinical laboratory tests.
- Plasma steady-state DTG tmax and t1/2
- (and 2 more...)
|
32 |
All |
18 Years to 65 Years (Adult) |
NCT01563328 |
115697 |
|
March 1, 2012 |
May 1, 2012 |
May 1, 2012 |
March 26, 2012 |
March 28, 2017 |
|
- GSK Investigational Site
Austin, Texas, United States
|
13 |
NCT01579214 |
Completed Has Results |
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda |
|
- Other: Cellular Phone Text Messages
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- Mbarara University of Science and Technology
- John E. Fogarty International Center (FIC)
- Harvard University
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result
- Clinic Return Within 28 Days of Abnormal CD4 Count Result
|
183 |
All |
18 Years and older (Adult, Senior) |
NCT01579214 |
2011P001538 R24TW007988 |
|
July 2012 |
December 2013 |
April 2015 |
April 17, 2012 |
January 4, 2018 |
December 8, 2017 |
- ISS Clinic, Mbarara Regional Referral Hospital
Mbarara, Uganda
|
14 |
NCT01875952 |
Unknown † |
Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL) |
- Human Immunodeficiency Virus (HIV)
- Tuberculosis (TB)
- Latent Tuberculosis Infection (LTI)
|
|
Interventional |
Phase 4 |
- Instituto Nacional de Salud Publica, Mexico
- Instituto Nacional de Enfermedades Respiratorias
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Production of interferon gamma, in response to treatment of latent infection
|
100 |
All |
18 Years to 60 Years (Adult) |
NCT01875952 |
Informed Consent:552 / 306 000000000014520 |
HIV/TB |
May 2010 |
June 2012 |
June 2013 |
June 12, 2013 |
June 12, 2013 |
|
- Instituto Nacional de Salud Publica
Mexico, Cuernavaca Morelos, Mexico - Clínica Especializada CONDESA
Mexico City, D.F, Mexico
|
15 |
NCT01565889 |
Completed Has Results |
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients. |
|
- Drug: SOF
- Drug: EFV/FTC/TDF
- Drug: EFV
- (and 8 more...)
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
- Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
- Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
- (and 3 more...)
|
52 |
All |
21 Years and older (Adult, Senior) |
NCT01565889 |
P7977-1910 |
|
March 2012 |
August 2013 |
November 2013 |
March 29, 2012 |
October 1, 2014 |
October 1, 2014 |
- Fundacion de Investigacion de Diego
San Juan, Puerto Rico
|
16 |
NCT01575938 |
Completed |
HIV Prevention Intervention for Young Transgender Women |
- Sexual Transmission of Infection
|
- Behavioral: HIV prevention intervention
- Behavioral: Diet and Nutrition
|
Interventional |
Not Applicable |
- Ann & Robert H Lurie Children's Hospital of Chicago
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months
|
300 |
Female |
16 Years to 29 Years (Child, Adult) |
NCT01575938 |
R01MH094323 |
LifeSkills |
March 2012 |
October 2015 |
October 2016 |
April 12, 2012 |
December 5, 2017 |
|
- Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States - The Fenway Institute
Boston, Massachusetts, United States
|
17 |
NCT01562132 |
Terminated Has Results |
Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection |
- Cryptococcal Infection Disseminated
|
- Drug: Flucytosine and fluconazole
- Drug: Fluconazole
|
Interventional |
Phase 2 |
- Yale University
- National Institute of Neurological Disorders and Stroke (NINDS)
- Kenya Medical Research Institute
- (and 2 more...)
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Survival at 12 Weeks
- Survival at 2 Weeks
- Survival at 24 Weeks
- (and 8 more...)
|
6 |
All |
18 Years and older (Adult, Senior) |
NCT01562132 |
R21NS077858-01 |
SToP-Crypto |
September 2013 |
July 2014 |
July 2014 |
March 23, 2012 |
August 31, 2015 |
August 31, 2015 |
- Family AIDS Care and Education Services
Kisumu, Nyanza, Kenya - Family AIDS Care and Education Services
Sindo, Nyanza, Kenya
|
18 |
NCT01581086 |
Completed |
Vascular Subphenotypes of Lung Disease in HIV & COPD |
- Pulmonary Artery Hypertension
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- elevated NT-proBNP as a biomarker
|
30 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01581086 |
VAST11060550 |
VAST |
January 2012 |
May 2016 |
January 2017 |
April 19, 2012 |
June 21, 2017 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
19 |
NCT01567722 |
Recruiting |
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies |
- Anal Cancer
- Cervical Cancer
- Lung Cancer
- Lymphoma
|
- Genetic: DNA analysis
- Genetic: RNA analysis
- Genetic: gene expression analysis
- (and 5 more...)
|
Observational |
|
- AIDS Malignancy Consortium
- National Cancer Institute (NCI)
- The EMMES Corporation
- (and 2 more...)
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Mutational spectrum of each type of HIV-1 associated malignancy
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT01567722 |
AMC-083 CDR0000729843 U01CA121947 |
|
July 2012 |
June 2020 |
June 2020 |
March 30, 2012 |
November 17, 2017 |
|
- Moores UCSD Cancer Center
La Jolla, California, United States - UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States - University of Miami
Miami, Florida, United States - (and 11 more...)
|