| 1 |
NCT01686750 |
Completed |
Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations |
|
- Behavioral: Integrated care centers
|
Interventional
|
Not Applicable |
- Johns Hopkins University
- National Institute on Drug Abuse (NIDA)
- National Institute of Mental Health (NIMH)
- (and 2 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion reporting HIV testing in the prior 12 months
- Proportion of HIV-infected participants aware of status
- Proportion of HIV-infected participants visiting an HIV treatment provider in prior 6 months
- (and 13 more...)
|
48272 |
All |
18 Years and older (Adult, Older Adult) |
NCT01686750 |
NA_00047702
R01DA032059
R01MH089266 |
|
October 2012 |
June 2017 |
June 2017 |
September 18, 2012 |
March 21, 2018 |
|
- YR Gaitonde Center for AIDS Research and Education
Chennai, Tamil Nadu, India
|
|
| 2 |
NCT01683461 |
Completed |
Efficacy of HIV Post-Test Support for ANC in South Africa |
- HIV
- Acquired Immunodeficiency Syndrome
|
- Behavioral: Enhanced Counseling
- Behavioral: Standard of Care
|
Interventional
|
Not Applicable |
- University of North Carolina, Chapel Hill
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- University of KwaZulu
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Incidence of sexually transmitted disease
- Condom use
|
1500 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01683461 |
07-1070
R01HD050134 |
SAHAPS |
May 2008 |
December 2011 |
December 2011 |
September 11, 2012 |
September 12, 2012 |
|
- University of KwaZulu-Natal
Durban, South Africa
|
|
| 3 |
NCT01702974 |
Completed |
Immune Reconstitution in HIV Disease (IREHIV) |
|
- Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
- Drug: Placebo tablets
|
Interventional
|
Phase 2 |
- Karolinska Institutet
- Addis Ababa University
- Armauer Hansen Research Institute, Ethiopia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- HIV viral load
- Clinical secondary endpoints
- Laboratory secondary endpoints
|
279 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01702974 |
IREHIV-2012 |
IREHIV |
September 2012 |
August 2015 |
August 2015 |
October 10, 2012 |
February 5, 2016 |
|
- Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine
Addis Ababa, Lideta sub city, Ethiopia
|
|
| 4 |
NCT01956396 |
Completed |
Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe |
- Circumcision Adult
- HIV CDC Category B2
- HIV Infections
|
|
Interventional
|
Phase 1 |
- Ministry of Health and Child Welfare, Zimbabwe
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe
- Evaluating the procedure duration
- Evaluating the pain at key time points
- (and 9 more...)
|
53 |
Male |
18 Years to 30 Years (Adult) |
NCT01956396 |
MRCZ/A/1628 Safety Study |
ZW-01 |
October 2011 |
November 2011 |
November 2011 |
October 8, 2013 |
October 8, 2013 |
|
- Znfpc Spilhaus Center
Harare, Zimbabwe
|
|
| 5 |
NCT01694420 |
Completed
Has Results |
Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet |
|
- Drug: (FDC) ELV/COBI/FTC/TDF
|
Interventional
|
Phase 3 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24
- Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48
- Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+
- Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF
|
33 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01694420 |
Pro00035447
IN-US-236-0124 |
PHI04 |
September 2012 |
April 2016 |
February 2017 |
September 27, 2012 |
April 12, 2017 |
December 23, 2016 |
- UNC at Chapel Hill
Chapel Hill, North Carolina, United States - Duke University Medical Center
Durham, North Carolina, United States
|
|
| 6 |
NCT01694017 |
Completed |
Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy |
|
- Drug: Tenofovir
- Drug: Zidovudine
|
Interventional
|
Phase 4 |
- Tufts University
- Christian Medical College, Vellore, India
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Viral suppression
- Change in CD4 levels
- Drug related toxicity
- (and 3 more...)
|
68 |
All |
18 Years and older (Adult, Older Adult) |
NCT01694017 |
10465 |
|
November 2012 |
August 2014 |
August 2014 |
September 26, 2012 |
November 24, 2014 |
|
- Christian Medical College
Vellore, Tamilnadu, India
|
|
| 7 |
NCT01683643 |
Completed |
Screening, Brief Intervention, and Referral to Treatment for Offenders |
- Substance Use
- HIV Infections
|
- Behavioral: SBIRT
- Behavioral: Control Group
|
Interventional
|
Not Applicable |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- A reduction in the use of drugs and alcohol
- Participation in treatment
- Rearrest and incarceration
- (and 3 more...)
|
800 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT01683643 |
R01DA031879 |
SBIRT |
April 2012 |
March 31, 2017 |
March 31, 2017 |
September 12, 2012 |
May 10, 2017 |
|
- University of California
Los Angeles, California, United States
|
|
| 8 |
NCT01728961 |
Terminated |
Pharmacology of Antimalarial Therapy With or Without Antiretroviral Therapy |
|
- Drug: Artemether/Lumefantrine (AL)
|
Interventional
|
Phase 4 |
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the curve from time zero to last quantifiable concentration (AUC)
- Toxicity
- Maximum observed plasma concentration (Cmax)
- (and 3 more...)
|
19 |
All |
3 Years to 12 Years (Child) |
NCT01728961 |
IMPAACT P1079
U01AI068632 |
|
February 2012 |
March 2014 |
March 2014 |
November 20, 2012 |
May 19, 2014 |
|
- College of Med. JHU CRS (30301)
Blantyre, Malawi - University of North Carolina Lilongwe (12001)
Lilongwe, Malawi - Makerere University - JHU Research Collaboration (30293)
Kampala, Uganda
|
|
| 9 |
NCT01956370 |
Completed |
Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting |
|
- Device: PrePex™ device for adult male circumcision
- Procedure: Surgical circumcision
|
Interventional
|
Phase 2 |
- Ministry of Health and Child Welfare, Zimbabwe
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Procedure time
- Expectations of men regarding the procedure
- Satisfaction rate of the procedure
- (and 9 more...)
|
240 |
Male |
18 Years to 30 Years (Adult) |
NCT01956370 |
MRCZ/A/1628 Comparative study |
|
November 2011 |
February 2012 |
February 2012 |
October 8, 2013 |
October 8, 2013 |
|
- Znfpc Spilhaus Center
Harare, Zimbabwe
|
|
| 10 |
NCT01694121 |
Active, not recruiting |
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men |
|
- Behavioral: MEN Count
- Behavioral: Comparison
|
Interventional
|
Not Applicable |
- University of California, San Diego
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- condom use/unprotected sex
- HIV/STI testing
|
455 |
Male |
18 Years to 40 Years (Adult) |
NCT01694121 |
R01MH096657 |
MEN Count |
March 2013 |
April 2017 |
May 2018 |
September 26, 2012 |
November 24, 2017 |
|
- George Washington University
Washington, District of Columbia, United States
|
|
| 11 |
NCT01712425 |
Completed |
Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals |
|
- Biological: 0-24 week prime/boost regimen
- Biological: 0-8 week prime/boost regimen
|
Interventional
|
Phase 1 |
- IrsiCaixa
- Fundacio Lluita Contra la SIDA
- Hospital Clinic of Barcelona
- (and 2 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Grade 3 or 4 local reaction
- Grade 3 or 4 systemic reaction
- Serious adverse event, including laboratory abnormalities.
- (and 5 more...)
|
48 |
All |
18 Years to 60 Years (Adult) |
NCT01712425 |
ChAd-MVA.HIVconsv-BCN01
2011-000846-39 |
|
October 2012 |
October 2015 |
October 2015 |
October 23, 2012 |
April 29, 2016 |
|
- Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain - Clinic de Barcelona Hospital
Barcelona, Spain
|
|
| 12 |
NCT01701206 |
Completed |
HOPE (Harnessing Online Peer Education): Using Online Social Networks for HIV Prevention and Testing |
|
- Behavioral: HIV knowledge Intervention
|
Interventional
|
Not Applicable |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Other
|
- HIV self-testing-Number of participants who request an HIV self-testing kit
|
558 |
Male |
18 Years to 100 Years (Adult, Older Adult) |
NCT01701206 |
K01MH090884 |
HOPE |
July 2009 |
July 2015 |
July 2015 |
October 5, 2012 |
May 3, 2017 |
|
- University of California, Los Angeles
Los Angeles, California, United States - Epicentro Commun
Lima, Peru
|
|
| 13 |
NCT01689545 |
Completed |
Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU |
|
- Behavioral: Individual level
- Behavioral: Structural level
- Behavioral: Individual level standard of care
- Behavioral: Structural level standard of care
|
Interventional
|
Not Applicable |
- Johns Hopkins Bloomberg School of Public Health
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- HIV injecting risk behavior
- HIV sexual risk behavior
- HIV incidence
|
2175 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01689545 |
5R01DA022962 |
|
December 2007 |
April 2013 |
April 2013 |
September 21, 2012 |
June 5, 2014 |
|
- Center for Preventive Medicine
Thai Nguyen, Vietnam
|
|
| 14 |
NCT01688167 |
Completed |
Increasing Availability and Acceptability of Circumcision in Zambia |
|
- Behavioral: MC and sexual risk reduction
|
Interventional
|
Not Applicable |
- University of Miami
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Prevention
|
- Change in likelihood of undergoing male circumcision across the study using stages of change model
- Uptake of male circumcision
|
1468 |
All |
18 Years and older (Adult, Older Adult) |
NCT01688167 |
20110290
R01MH095539 |
|
January 2012 |
November 2014 |
November 2014 |
September 19, 2012 |
July 10, 2015 |
|
- University of Zambia Teaching Hospital
Lusaka, Zambia
|
|
| 15 |
NCT01701635 |
Active, not recruiting |
SANKOFA Pediatric HIV Disclosure Intervention |
|
- Behavioral: Disclosure intervention
- Behavioral: Enhanced usual care
|
Interventional
|
Not Applicable |
- Yale University
- Purdue University
- University of Ghana
- Kwame Nkrumah University of Science and Technology
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HIV disclosure rate
- Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status
- Medication adherence of children
- (and 2 more...)
|
446 |
All |
7 Years to 18 Years (Child, Adult) |
NCT01701635 |
R01HD074253
NIH/NICHD |
|
January 2013 |
June 30, 2017 |
June 30, 2018 |
October 5, 2012 |
January 25, 2018 |
|
- Komfo Anoky Teaching Hospital
Kumasi, Ashanti Region, Ghana - Korle-Bu Teaching Hospital
Accra, Greater Accra Region, Ghana
|
|
| 16 |
NCT01711411 |
Completed |
Observational Study of Male Circumcision Using PrePex Device |
|
- Device: PrePex device for male circumcision
|
Observational
|
|
- FHI 360
- Bill and Melinda Gates Foundation
- University of Illinois at Chicago
- (and 2 more...)
|
Other |
|
- The incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment.
- Acceptability of PrePex procedures among Kenyan clients
- Acceptability of PrePex procedures among Kenyan male circumcision providers
- Proportion of men ineligible for circumcision with PrePex
|
427 |
Male |
18 Years to 49 Years (Adult) |
NCT01711411 |
10376 |
|
November 2012 |
September 2013 |
September 2013 |
October 22, 2012 |
November 27, 2013 |
|
- Nyanza Reproductive Health Society
Kisumu, Nyanza, Kenya
|
|
| 17 |
NCT01690442 |
Completed |
HIV Prevention for Injecting Drug Users in Kazakhstan |
|
- Behavioral: Couples Based HIV/STI Risk Reduction Intervention (CHSR)
- Behavioral: Renaissance Wellness Promotion (WP)
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The proportion of condom protected acts of vaginal and anal intercourse
- The number of incidents of unclean syringes or needles in the past 90 days
- Proportion of injection acts in which unclean needles or syringes were used in the past 90 days
- (and 2 more...)
|
600 |
All |
18 Years and older (Adult, Older Adult) |
NCT01690442 |
AAAD2056 |
|
May 2008 |
November 2012 |
November 2012 |
September 21, 2012 |
February 27, 2014 |
|
- Global Health Research Center of Central Asia
Almaty, Kazakhstan
|
|
| 18 |
NCT01697046 |
Unknown † |
A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection |
|
- Drug: Truvada and Isentress
|
Interventional
|
Phase 3 |
- Projeto Praça Onze
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
|
65 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01697046 |
IIS# 39550 |
PERIEP |
November 2012 |
March 2014 |
March 2014 |
October 2, 2012 |
October 2, 2012 |
|
- Monica Barbosa de Souza
Rio de Janeiro, RJ, Brazil
|
|
| 19 |
NCT01776151 |
Completed |
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START) |
- Cardiovascular Diseases
- HIV
|
|
Observational
|
|
- University of Minnesota - Clinical and Translational Science Institute
|
Other |
- Time Perspective: Prospective
|
- Change from baseline in large artery elasticity (LAE
- Change from baseline in small artery elasticity (SAE)
- Changes in plasma markers of thrombosis and fibrinolysis
|
337 |
All |
18 Years and older (Adult, Older Adult) |
NCT01776151 |
0603M83587 START 001D |
|
November 2009 |
September 2015 |
September 2015 |
January 25, 2013 |
December 2, 2015 |
|
- Henry Ford Health System
Detroit, Michigan, United States
|
|
| 20 |
NCT01710397 |
Active, not recruiting |
Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study) |
|
- Other: Rapid ART initiation
|
Interventional
|
Not Applicable |
- Boston University
- National Institute of Allergy and Infectious Diseases (NIAID)
- University of Witwatersrand, South Africa
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion non-pregnant subjects virally suppressed at routine six-month viral load
- Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery
- Average cost per non-pregnant patient who is alive, in care, and virally suppressed within 10 months of study enrollment
- (and 6 more...)
|
531 |
All |
18 Years and older (Adult, Older Adult) |
NCT01710397 |
H-31880
1U01AI100015-01 |
RapIT |
May 2013 |
July 2015 |
December 31, 2018 |
October 19, 2012 |
March 13, 2018 |
|
- Thuthukani Primary Health Clinic
Johannesburg, Gauteng, South Africa - Themba Lethu Clinic, Helen Joseph Hospital
Johannesburg, Gauteng, South Africa
|
|
| 21 |
NCT01701882 |
Completed |
A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine |
|
- Drug: tenofovir/emtricitabine/rilpivirine
|
Interventional
|
Phase 3 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Resolution of toxicity after 12 weeks
- Resolution of toxicity after 24 weeks
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT01701882 |
SSAT 047 |
|
September 2012 |
November 2013 |
November 2013 |
October 5, 2012 |
July 26, 2017 |
|
- St Stephen's AIDS Trust
London, United Kingdom
|
|
| 22 |
NCT01697540 |
Recruiting |
Management of Highly Active Anti-retroviral Therapy-related Hyperlipidemia Among HIV-infected Patients in Taiwan |
|
|
Observational
|
|
- Kaohsiung Medical University Chung-Ho Memorial Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
100 |
All |
Child, Adult, Older Adult |
NCT01697540 |
KMUHIRB-2012-05-05(I) |
|
September 2012 |
September 2019 |
|
October 2, 2012 |
April 28, 2017 |
|
- Tropical medicine center
Kaohsiung, Taiwan
|
|
| 23 |
NCT01956383 |
Completed |
Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses |
- Circumcision Adult
- HIV CDC Category B2
|
|
Interventional
|
Phase 3 |
- Ministry of Health and Child Welfare, Zimbabwe
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- To assess the safety of the PrePex device when circumcision is performed by nurses
- Evaluate the training needs of PrePexTM deployment using nurses
- Observation of in-field usability of device
- (and 5 more...)
|
603 |
Male |
18 Years to 30 Years (Adult) |
NCT01956383 |
MRCZ/A/1628 Nurses Study |
|
April 2012 |
September 2012 |
September 2012 |
October 8, 2013 |
October 8, 2013 |
|
- Znfpc Spilhaus Center
Harare, Zimbabwe
|
|
| 24 |
NCT01691794 |
Completed
Has Results |
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients |
|
- Drug: Atazanavir
- Drug: Ritonavir
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events
- Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4
- Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)
|
108 |
All |
6 Years to 17 Years (Child) |
NCT01691794 |
AI424-452
2011-003300-21 |
|
November 30, 2012 |
October 31, 2014 |
February 20, 2017 |
September 25, 2012 |
April 27, 2018 |
November 30, 2015 |
- Phoenix Children'S Hospital
Phoenix, Arizona, United States - Grady Health System Ponce Family And Youth Clinic
Atlanta, Georgia, United States - Children'S Medical Center Of Dallas
Dallas, Texas, United States - (and 24 more...)
|
|
| 25 |
NCT01692470 |
Withdrawn |
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection |
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Number of patients with incidence of adverse events
- Number of patients with incidence of discontinuation of study medication due to adverse events
- Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment
- (and 3 more...)
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT01692470 |
CR100849
TMC278IFD4002
EDUPHLMA1 |
|
June 2013 |
December 2015 |
December 2015 |
September 25, 2012 |
December 2, 2015 |
|
|
|
| 26 |
NCT01687504 |
Unknown † |
Pharmacokinetics of Anti-TB Drugs in HIV/TB Co-infected Children in Ghana |
|
|
Observational
|
|
- The Miriam Hospital
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Descriptive statistics of PK parameters (Cmax, Tmax, AUC0-8h) of rifampin, isoniazid, pyrazinamide and ethambutol in children with TB with and without HIV coinfection
- Frequency of liver enzymes elevations compare to baseline, skin rashes, nausea, vomiting and treatment discontinuation or modifications due to drug side effects in children with TB with and without HIV coinfection
- Relationship between genetic polymorphisms of N-acetyltransferase type 2 (NAT2) enzyme and isoniazid plasma Cmax and AUC in Ghanaian children with TB with and without HIV
- (and 4 more...)
|
106 |
All |
3 Months to 14 Years (Child) |
NCT01687504 |
PK-PTBHIV01
R01HD071779 |
|
October 2012 |
May 2017 |
May 2017 |
September 19, 2012 |
October 11, 2012 |
|
- Komfo Anokye Teaching Hospital
Kumasi, Ghana
|
|
| 27 |
NCT01692236 |
Terminated |
Brain Imaging for HIV-Associated Thinking and Mood Disorders |
- Human Immunodeficiency Virus
- Neurocognitive Impairment
|
|
Observational
|
|
- National Institutes of Health Clinical Center (CC)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Time Perspective: Prospective
|
- Neuropsychologic testing scores
- Serum biomarkers of cardiovascular disease and inflammation
- MRI brain and vascular findings
|
84 |
All |
25 Years to 61 Years (Adult) |
NCT01692236 |
120200
12-CC-0200 |
|
September 13, 2012 |
|
April 4, 2018 |
September 25, 2012 |
June 19, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 28 |
NCT01695954 |
Unknown † |
Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz |
|
- Drug: Pitavastatin
- Drug: Darunavir
- Drug: Ritonavir
- Drug: Efavirenz
|
Interventional
|
Phase 1 |
- New York University School of Medicine
- Bellevue/NYU AIDS Clinical Trials Unit
- Kowa Pharmaceuticals America, Inc.
- University at Buffalo
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- AUC of pitavastatin after coadministration of efavirenz. AUC of pitavastatin after coadministration of darunavir with ritonavir. AUC of efavirenz after coadministration of pitavastatin. AUC of darunavir after coadministration of pitavastatin.
- Other pharmacokinetic parameters of pitavastatin and efavirenz and of pitavastatin and darunavir+ritonavir. Lipid measurements at days 0,4,14 and 18.
|
28 |
All |
18 Years to 60 Years (Adult) |
NCT01695954 |
NYU 11-01787 |
|
May 2012 |
October 2012 |
October 2012 |
September 28, 2012 |
September 28, 2012 |
|
- Bellevue/NYU AIDS Clinical Trials Unit
New York, New York, United States
|
|
| 29 |
NCT01694862 |
Completed |
Benefits and Costs of Integrating Sexual-Reproductive Health and HIV Services in Kenya and Swaziland |
|
- Procedure: Integrated FP/PNC service delivery
|
Interventional
|
Not Applicable |
- London School of Hygiene and Tropical Medicine
- Population Council
- International Planned Parenthood Federation
- Bill and Melinda Gates Foundation
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Unintended pregnancies
- HIV risk behaviour
|
4763 |
Female |
15 Years to 49 Years (Child, Adult) |
NCT01694862 |
Integra Initiative |
Integra |
January 2009 |
December 2012 |
June 2013 |
September 27, 2012 |
May 16, 2016 |
|
- Multiple MoH facilities in Kenya
Thika, Nyeri and others, Kenya - Multiple MoH locations in Swaziland
Manzini, Swaziland
|
|
| 30 |
NCT01704781 |
Completed
Has Results |
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART) |
|
- Drug: Lenalidomide
- Drug: Lenalidomide placebo
- Drug: Vacc-4X
- Drug: rhuGM-CSF
|
Interventional
|
Phase 1
Phase 2 |
- Bionor Immuno AS
- Celgene Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity
- Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time
- Part B: Change in CD4 Count
- (and 4 more...)
|
36 |
All |
18 Years to 55 Years (Adult) |
NCT01704781 |
CT-BI Vacc-4x/IMiD-2010/1 |
IMID |
September 2012 |
August 2014 |
August 2014 |
October 11, 2012 |
March 8, 2017 |
March 8, 2017 |
- EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125
Berlin, Germany - Charite Campus, Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Infektiologie Station 59 (Suedring 11) Augustenburger Platz 1
Berlin, Germany - University Medical Center Hamburg-Eppendorf
Hamburg, Germany - Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Köln, Germany
|
|
| 31 |
NCT01701895 |
Completed |
Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera |
|
|
Observational
|
|
- Prema Menezes, PhD, PA-C
- Gilead Sciences
- University of North Carolina, Chapel Hill
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Compliance with meal instruction
- Evaluation of subjects' attitudes toward contraception
- Association between caloric intake and virologic suppression
- Assessment of medication adherence
|
33 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01701895 |
CID 1213 - IRB 12-1550 |
|
October 2012 |
October 2015 |
October 2015 |
October 5, 2012 |
December 2, 2015 |
|
- University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
|
|
| 32 |
NCT01704144 |
Unknown † |
Rifampin and Efavirenz Interactions in Older Children |
|
|
Observational
|
|
- The Miriam Hospital
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Area under time curve from time 0-24 hours(AUC0-24h) of efavirenz
- Number of children with grade 3 or 4 liver enzymes elevations compared to baseline, new onset of skin rash, nausea, vomiting or treatment modification due to drug side effects
- Number of children with efavirenz 24-hour post-dose concentration (C24h) < 1000 ng/mL
- (and 3 more...)
|
160 |
All |
3 Years to 14 Years (Child) |
NCT01704144 |
PK-PTBHIV03
R01HD071779 |
|
October 2012 |
May 2017 |
May 2017 |
October 11, 2012 |
October 17, 2012 |
|
- Komfo Anokye Teaching Hospital
Kumasi, Ghana
|
|
| 33 |
NCT01705873 |
Unknown † |
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen |
- HIV
- Hypercholesterolemia
- Dyslipidemia
|
|
Observational
|
|
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Risk for CV events
- All cause mortality
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT01705873 |
ANV-10-0165 |
|
September 2012 |
March 2013 |
August 2013 |
October 12, 2012 |
October 12, 2012 |
|
- Helios Salud
Buenos Aires, Argentina
|
|
| 34 |
NCT01699633 |
Unknown † |
Rifampin and Nevirapine Interactions in Young Children |
|
|
Observational
|
|
- The Miriam Hospital
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Area under time curve (AUC) of nevirapine
- Number of children with grade 3 or 4 liver enzymes elevations compared to baseline, new onset of skin rash, nausea, vomiting or treatment modification due to drug side effects
- Number of children with nevirapine 12-hour post-dose concentration (C12h) < 3000 ng/mL
- (and 2 more...)
|
58 |
All |
3 Months to 35 Months (Child) |
NCT01699633 |
PK-TBHIV02
R01HD071779 |
|
October 2012 |
May 2017 |
May 2017 |
October 4, 2012 |
October 12, 2012 |
|
- Komfo Anokye Teaching Hospital
Kumasi, Ghana
|
|
| 35 |
NCT01707472 |
Completed |
A Phase 2a Study of Simtuzumab in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis |
- Liver Fibrosis
- Hepatitis C
- HIV
- HIV/HCV Co-infection
|
|
Interventional
|
Phase 2 |
- Gilead Sciences
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Industry / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events following administration of simtuzumab in HIV and/or Hepatitis C-infected subjects with evidence of liver fibrosis
- Change in portal pressure gradient before and after treatment
- Change in liver fibrosis stage as seen on liver biopsy before and after treatment
- Change in liver fibrosis as estimated by magnetic resonance (MR) elastography before and after treatment
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT01707472 |
GS-US-321-0107 |
|
August 2012 |
October 2014 |
October 2014 |
October 16, 2012 |
December 16, 2015 |
|
- NIH Department of Laboratory Medicine
Bethesda, Maryland, United States
|
|
| 36 |
NCT01699841 |
Completed |
Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events |
- HIV
- Malnutrition
- Cryptosporidiosis
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Breast milk composition
- Infant anthropometric measures
- Infant infectious disease events
|
208 |
All |
Child, Adult, Older Adult |
NCT01699841 |
IRB 1111002616 |
|
April 2012 |
June 15, 2013 |
June 30, 2013 |
October 4, 2012 |
November 1, 2017 |
|
- Kisesa Health Centre
Kisesa, Tanzania
|
|
| 37 |
NCT01697007 |
Completed |
A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique |
- Vaccines
- HIV
- Safety
- Immunogenicity
|
- Biological: HIVIS DNA vaccine
- Device: Zetajet
- Device: Derma Vax Electroporation
- Biological: Modified Vaccinia Ankara (MVA-CDMR)
|
Interventional
|
Phase 2 |
- Muhimbili University of Health and Allied Sciences
- Swedish Institute for Infectious Disease Control
- Karolinska Institutet
- (and 7 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|
- The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline
- Grade 3 or above local and systemic solicited adverse events
- The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining
|
198 |
All |
18 Years to 40 Years (Adult) |
NCT01697007 |
TaMoVac II |
TaMoVac II |
November 2012 |
December 2014 |
June 2015 |
October 2, 2012 |
June 29, 2015 |
|
- Instituto Nacional de Saude
Maputo, Mozambique - Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania - Mbeya Medical Research Programme
Mbeya, Tanzania
|
|
| 38 |
NCT01700790 |
Recruiting |
Pharmacokinetic Study of Super-boosted Lopinavir/Ritonavir Given With Rifampin |
|
- Drug: Lopinavir/ritonavir and ritonavir
|
Interventional
|
Phase 4 |
- University of Miami
- Oswaldo Cruz Foundation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with expected pre dose concentration of lopinavir.
- Proportion of patients with successful treatment of HIV therapy.
- Proportion of patients with expected AUC of rifampin
- (and 3 more...)
|
12 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01700790 |
20100325 |
|
February 2016 |
December 2018 |
March 2019 |
October 4, 2012 |
November 7, 2017 |
|
- Instituto Nacional de Infectologia Evandro Chagas - Fiocruz(INI), Laboratorio de Pesquisa Clinica em Micobacterioses(LAPCLINTB)
Rio de Janeiro, RJ, Brazil
|
|
| 39 |
NCT01690494 |
Recruiting |
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders |
- Sexually Transmitted Diseases
- Unsafe Sex
- Substance-Related Disorders
|
- Behavioral: PACT
- Behavioral: TAU
|
Interventional
|
Not Applicable |
- Columbia University
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change in biologically confirmed sexually transmitted infections
- Change in proportion of unprotected sexual acts
- Change in drug use
- (and 2 more...)
|
480 |
All |
18 Years and older (Adult, Older Adult) |
NCT01690494 |
AAAK0206
1R01DA033168-01A1 |
PACT |
June 2013 |
July 2017 |
July 2017 |
September 21, 2012 |
January 27, 2017 |
|
- Columbia University
New York, New York, United States
|
|
| 40 |
NCT01704742 |
Withdrawn |
Prospective Study of Lymphoproliferative Diseases |
- Non-Hodgkin's Lymphoma
- Hodgkin's Lymphoma
|
|
Observational
|
|
- West Virginia University
- Kenyatta National Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya
- To perform a comprehensive clinicopathological study in these subjects.
- Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya
|
0 |
All |
Child, Adult, Older Adult |
NCT01704742 |
WVU1411 |
|
|
|
|
October 11, 2012 |
November 8, 2016 |
|
- West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States - Kenyatta National Hospital (University of Nairobi)
Nairobi, Kenya
|
|
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