| 1 |
NCT01621412 |
Completed |
HIV Disclosure and Medication Adherence, a Pilot Study |
|
|
Observational |
|
- Policlinique Médicale Universitaire
- Centre Hospitalier Universitaire Vaudois
- Swiss HIV Cohort Study
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT01621412 |
RSAD-VIH-2011 |
RSAD-VIH-11 |
April 2012 |
June 2013 |
June 2013 |
June 18, 2012 |
December 22, 2015 |
|
- Policlinique Médicale Universitaire
Lausanne, Vaud, Switzerland
|
| 2 |
NCT01625091 |
Completed
Has Results |
Clinical Trial to Reduce Drinking in Women With HIV |
|
- Drug: Naltrexone
- Drug: Placebo
|
Interventional |
Phase 3 |
- University of Florida
- Florida International University
- University of Miami
- (and 2 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants Who Quit Hazardous Drinking
- Number of Binge Drinking Days
- Drinking Problems (SIP-2R Score)
- Craving for Alcohol
|
194 |
Female |
18 Years and older (Adult, Senior) |
NCT01625091 |
86-2012-N
U01AA020797-01 |
WHATIF |
December 2012 |
July 2016 |
July 2016 |
June 21, 2012 |
April 6, 2018 |
August 2, 2017 |
- University of Miami
Coral Gables, Florida, United States - Florida International University
Miami, Florida, United States
|
| 3 |
NCT01617096 |
Completed |
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women |
|
- Combination Product: Dapivirine Vaginal Ring
- Combination Product: Placebo Ring
|
Interventional |
Phase 3 |
- International Partnership for Microbicides, Inc.
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Efficacy as determined by the proportion of women in each arm with HIV-1 seroconversion after 120 endpoints are observed in the trial.
|
3540 |
Female |
18 Years to 45 Years (Adult) |
NCT01617096 |
MTN-020
UM1AI068633-06 |
ASPIRE |
June 2012 |
June 2015 |
June 2015 |
June 12, 2012 |
September 7, 2017 |
|
- College of Medicine - Johns Hopkins University Research Project
Blantyre, Malawi - UNC Project
Lilongwe, Malawi - CAPRISA, eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa - (and 4 more...)
|
| 4 |
NCT01629316 |
Completed |
Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX |
|
- Behavioral: Text reminders, counseling, and link coordination
- Behavioral: Standard of care - control arm
|
Interventional |
Not Applicable |
- University of North Carolina, Chapel Hill
- National Institutes of Health (NIH)
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- HIV RNA level (Viral Load)
|
381 |
All |
18 Years and older (Adult, Senior) |
NCT01629316 |
CID 1007 - UNC IRB 10-1183
R01DA030793-01 |
imPACT |
March 2012 |
May 2015 |
May 2015 |
June 27, 2012 |
June 11, 2015 |
|
- University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States - Texas Christian University
Fort Worth, Texas, United States
|
| 5 |
NCT02934022 |
Completed |
Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients |
|
|
Interventional |
Not Applicable |
- Southern California Institute for Research and Education
- Pfizer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in absolute CD4 lymphocyte count after addition of maraviroc for 12 months to the subject's current highly active antiretroviral therapy (HAART) regimen.
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT02934022 |
WS719742 |
|
June 2012 |
December 2014 |
December 2014 |
October 14, 2016 |
October 14, 2016 |
|
- VA Long Beach Healthcare System
Long Beach, California, United States
|
| 6 |
NCT01638650 |
Completed |
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients |
|
- Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs)
- Drug: ritonavir
- Drug: saquinavir [Invirase]
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximal increase in QTc interval (continuous Holter 12-lead ECG monitoring time points Days 1, 3, 4, 7, 10 and 14)
- Pharmacokinetics: Plasma concentrations
- Pharmacodynamics: Change in HIV-RNA levels
- (and 3 more...)
|
23 |
All |
18 Years and older (Adult, Senior) |
NCT01638650 |
NP25607 |
|
January 2012 |
June 2012 |
June 2012 |
July 12, 2012 |
November 2, 2016 |
|
|
| 7 |
NCT01622673 |
Completed
Has Results |
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247) |
|
- Drug: Raltegravir
- Drug: TUMS® Ultra Strength
- Drug: MINTOX® Maximum Strength
|
Interventional |
Phase 1 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
- Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
- Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
- (and 5 more...)
|
27 |
All |
18 Years and older (Adult, Senior) |
NCT01622673 |
0518-247 |
|
June 2012 |
October 2012 |
October 2012 |
June 19, 2012 |
March 21, 2017 |
September 17, 2013 |
|
| 8 |
NCT01618305 |
Active, not recruiting |
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission |
|
- Drug: Lamivudine/zidovudine
- Drug: Efavirenz
- Drug: Raltegravir
|
Interventional |
Phase 4 |
- Westat
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Plasma HIV-1 viral load less than 200 copies/mL
- Number of participants who discontinue efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason (including loss to follow-up)
- Maternal adverse events of greater than or equal to Grade 3 as defined in the Division of AIDS (DAIDS) toxicity table
- (and 13 more...)
|
394 |
Female |
16 Years and older (Child, Adult, Senior) |
NCT01618305 |
P1081
10770
NICHD P1081 |
|
July 2013 |
August 2018 |
July 2019 |
June 13, 2012 |
March 2, 2018 |
|
- University of Southern California Medical Center
Los Angeles, California, United States - David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States - Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States - (and 23 more...)
|
| 9 |
NCT01618058 |
Enrolling by invitation |
Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials |
|
- Drug: No Investigational Product
|
Observational |
|
- International Partnership for Microbicides, Inc.
|
Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo.
|
150 |
Female |
18 Years to 45 Years (Adult) |
NCT01618058 |
IPM 007 |
|
June 2012 |
July 2019 |
July 2019 |
June 13, 2012 |
March 29, 2018 |
|
- Project Ubuzima
Kiyovu, Kigali, Rwanda - Qhakaza Mbokodo
Ladysmith, Kwazulu Natal, South Africa - Prevention for HIV and AIDS Project (PHIVA)
Pinetown, Kwazulu Natal, South Africa - (and 2 more...)
|
| 10 |
NCT01612455 |
Completed |
Linking Infectious and Narcology Care in Russia |
|
- Behavioral: LINC Case Management
|
Interventional |
Not Applicable |
- Boston Medical Center
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- 1) initiation of HIV care
- 2) retention in HIV care
- 3) appropriate HIV care
- (and 2 more...)
|
349 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01612455 |
H-30414
R01DA032082 |
LINC |
July 2012 |
January 2016 |
January 2016 |
June 5, 2012 |
July 21, 2017 |
|
- Botkin Infectious Disease Hospital
St. Petersburg, Russian Federation - City Addiction Hospital
St. Petersburg, Russian Federation - Pavlov State Medical University
St. Petersburg, Russian Federation
|
| 11 |
NCT01606722 |
Completed |
Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy |
|
- Drug: Darunavir/ritonavir
|
Observational |
|
- Hospitales Universitarios Virgen del Rocío
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Virological efficacy
- Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation
|
150 |
All |
18 Years to 65 Years (Adult) |
NCT01606722 |
LLC-DAR-2010-01 |
MonDar |
January 2010 |
June 2013 |
June 2013 |
May 28, 2012 |
July 11, 2013 |
|
- Hospital Universitarios Virgen del Rocio
Seville, Spain
|
| 12 |
NCT01621347 |
Completed |
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women |
|
|
Observational |
|
- Policlinique Médicale Universitaire
- Centre Hospitalier Universitaire Vaudois
- Swiss HIV Cohort Study
|
Other |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Change in patient adherence during pregnancy and postpartum
- Adherence barriers and facilitators
|
26 |
Female |
18 Years and older (Adult, Senior) |
NCT01621347 |
48/12 |
|
March 2012 |
August 2012 |
September 2012 |
June 18, 2012 |
December 22, 2015 |
|
- Policlinique Médicale Universitaire
Lausanne, Vaud, Switzerland
|
| 13 |
NCT01612858 |
Completed
Has Results |
Metabolic Abnormalities in HIV-infected Persons |
- Lipodystrophy
- HIV Infection
|
- Drug: Metformin
- Drug: Pioglitazone
|
Interventional |
Phase 4 |
- Tufts Medical Center
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
- Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01612858 |
CLAMP-K23
1K23DK079789-01A2 |
|
June 2011 |
November 2014 |
November 2014 |
June 6, 2012 |
June 20, 2016 |
June 20, 2016 |
- Tufts Medical Center
Boston, Massachusetts, United States
|
| 14 |
NCT01615601 |
Completed |
An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients |
- Human Immunodeficiency Virus (HIV)
|
- Drug: darunavir (PREZISTA)
- Drug: etravirine (INTELENCE)
- Drug: ritonavir
- Drug: Other antiretroviral medications
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change from Baseline in the patient's total score of the HIV Symptom Distress Module (HIV-SDM)
- Number of participants with Maintenance/achievement of virologic suppression at Week 24
- Number of participants with disappearance by Week 4 of at least one bothersome symptom identified at baseline by patient on HIV-SDM
- (and 3 more...)
|
77 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01615601 |
CR018595
TMC114HIV4068 |
POISE |
October 2011 |
April 2013 |
April 2013 |
June 8, 2012 |
May 22, 2014 |
|
|
| 15 |
NCT01616940 |
Completed |
Minority AIDS Initiative Retention and Re-Engagement Project |
|
- Behavioral: Enhanced Peer Intervention
|
Interventional |
Not Applicable |
- Boston University
- Care Resource
- The Brooklyn Hospital Center
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Number of participants retained continuously in quality HIV care
- Number of participants who are virally suppressed
- Change from Baseline in Health-related Quality of Life
- (and 2 more...)
|
348 |
All |
18 Years and older (Adult, Senior) |
NCT01616940 |
U69HA23262 |
|
September 2011 |
March 2014 |
March 2014 |
June 12, 2012 |
March 22, 2017 |
|
- Care Resource
Miami, Florida, United States - Center for Advancing Health Policy and Practice
Boston, Massachusetts, United States - PATH Center, The Brooklyn Hospital
Brooklyn, New York, United States - Puerto Rico Community Network for Clinical Research on AIDS
San Juan, Puerto Rico
|
| 16 |
NCT01625169 |
Completed
Has Results |
Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma |
|
- Drug: Etravirine pharmacokinetics in breast milk and plasma
|
Interventional |
Not Applicable |
- University of Southern California
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Peak Plasma Concentration of Etravirine in Plasma
- Peak Concentration of Etravirine in Breast Milk
- Area Under the Curve (AUC) 0-12 for Plasma
- (and 2 more...)
|
9 |
Female |
18 Years and older (Adult, Senior) |
NCT01625169 |
HS-09-00698 |
|
April 2010 |
December 2012 |
December 2012 |
June 21, 2012 |
August 13, 2014 |
August 7, 2014 |
- LAC+USC MCA Clinic
Los Angeles, California, United States
|
| 17 |
NCT01614626 |
Active, not recruiting |
Alcohol's Impact on Inflammatory Markers in HIV Disease - Russia ARCH Cohort |
|
|
Observational |
|
- Boston Medical Center
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Microbial translocation as measured by soluble CD14 (sCD14)
- Inflammation/altered coagulation as measured by IL-6/D-dimer
- Alcohol's association with immunologic aging as measured by flow cytometry
|
375 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01614626 |
H-31200
U01AA020780 |
|
November 2012 |
April 2018 |
April 2018 |
June 8, 2012 |
November 1, 2017 |
|
- Pavlov State Medical University
St. Petersburg, Russian Federation
|
| 18 |
NCT01601626 |
Terminated
Has Results |
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV |
- HIV Infection
- Tuberculosis
|
- Drug: Standard-dose Lopinavir/Ritonavir
- Drug: Double-dose Lopinavir/Ritonavir
- Drug: Raltegravir
- (and 6 more...)
|
Interventional |
Phase 2 |
- AIDS Clinical Trials Group
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.
- Percent of Participants Who Experienced Sputum Conversion at Week 8.
- Percent of Participants Who Experienced TB Treatment Failure
- (and 17 more...)
|
71 |
All |
18 Years and older (Adult, Senior) |
NCT01601626 |
ACTG A5290
1U01AI068636 |
|
July 13, 2013 |
January 19, 2017 |
June 28, 2017 |
May 18, 2012 |
February 13, 2018 |
February 13, 2018 |
- Hospital Nossa Senhora da Conceicao CRS (12201)
Porto Alegre, RS, Brazil - Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil - GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (31730)
Port Au Prince, Haiti - (and 6 more...)
|
| 19 |
NCT01608802 |
Completed |
Outcomes for Antiretroviral Therapy Patients Receiving Palliative Care |
|
- Other: Palliative care
- Other: Standard care
|
Interventional |
Phase 2
Phase 3 |
- King's College London
- University College, London
- University of Cape Town
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Self-report pain using the APCA African POS
- Psychological morbidity
- Quality of Life
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT01608802 |
6594/3200 |
TOPCare |
May 2011 |
May 2013 |
August 2013 |
May 31, 2012 |
June 10, 2014 |
|
- BOMU Hospital
Mombasa, Kenya - Ivan Toms Clinic
Cape Town, Western Cape, South Africa
|
| 20 |
NCT01605890 |
Completed |
Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients |
|
- Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .
|
Interventional |
Phase 2 |
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- Gilead Sciences
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of participants in therapeutic success
- Gain in CD4 lymphocytes count
- Tolerance of the treatment
- (and 8 more...)
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT01605890 |
2011-005038-20
ANRS 159 VIH-2 |
VIH-2 |
July 2012 |
December 2015 |
December 2015 |
May 25, 2012 |
July 12, 2016 |
|
- Hôpital Bichat-Claude Bernard
Paris, France
|
| 21 |
NCT01616420 |
Completed |
Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya |
|
- Other: Assisted-partner notification services
|
Interventional |
Not Applicable |
- University of Washington
- Kenya Ministry of Health
- University of Nairobi
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Number of partners testing for HIV
- Newly tested HIV-infected partners
- Number of partners linking to HIV care
- (and 3 more...)
|
2424 |
All |
18 Years and older (Adult, Senior) |
NCT01616420 |
43628 |
APS |
June 2012 |
August 2015 |
August 2015 |
June 11, 2012 |
April 10, 2017 |
|
- Karuri VCT
Kiambu, Kenya - Kiambu Hospital VCT
Kiambu, Kenya - Kirwara VCT
Kiambu, Kenya - (and 15 more...)
|
| 22 |
NCT01635504 |
Completed
Has Results |
HIV Posterior Cheek Enlargement |
- HIV Posterior Cheek Enlargement
|
- Biological: Botulinum toxin A
|
Interventional |
Not Applicable |
- University of British Columbia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A
- Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A
|
5 |
All |
19 Years and older (Adult, Senior) |
NCT01635504 |
H12-00990 |
|
October 2012 |
January 2015 |
January 2015 |
July 9, 2012 |
August 28, 2015 |
June 18, 2015 |
- Carruthers Dermatology Center
Vancouver, British Columbia, Canada
|
| 23 |
NCT01635153 |
Completed |
Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis |
|
- Dietary Supplement: Protein calorie supplement
- Dietary Supplement: Micronutrient
|
Interventional |
Phase 2 |
- Dartmouth-Hitchcock Medical Center
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in CD4 count
- BMI at 6 months
- Proportion of subjects who achieve 100 cell increase in CD4
|
151 |
Female |
18 Years and older (Adult, Senior) |
NCT01635153 |
DarDar 2-C CPHS 21592
RO1 503498 |
DarDar |
May 2012 |
July 2014 |
July 2014 |
July 9, 2012 |
February 10, 2015 |
|
- Infectious Disease Centre
Dar es Salaam, Tanzania
|
| 24 |
NCT01607541 |
Completed |
Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV |
|
- Behavioral: BCAP peer-driven intervention (PDI)
- Behavioral: Control intervention
|
Interventional |
Phase 2
Phase 3 |
- New York University
- National Institute on Drug Abuse (NIDA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- proportion of newly diagnosed HIV infections
- time to HIV clinical appointment
- time to initiation of HAART if medically indicated
- (and 2 more...)
|
3400 |
All |
18 Years to 60 Years (Adult) |
NCT01607541 |
R11-01257
R01DA032083 |
BCAP |
April 2012 |
February 2015 |
April 2016 |
May 30, 2012 |
June 9, 2016 |
|
- New York University College of Nursing
New York, New York, United States
|
| 25 |
NCT01620944 |
Terminated |
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC |
|
- Drug: Atazanavir
- Drug: Ritonavir
- Drug: Lamivudine
- Drug: Tenofovir/Emtricitabine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of subjects with HIV-1 RNA < 40 c/mL
- Proportion of subjects with HIV-1 RNA < 400 c/mL
- Incidence rates of SAEs and AEs leading to discontinuation through Weeks 48 and 96
- (and 2 more...)
|
3 |
All |
18 Years and older (Adult, Senior) |
NCT01620944 |
AI424-494
2011-006187-47 |
|
July 2012 |
October 2016 |
October 2016 |
June 15, 2012 |
November 27, 2013 |
|
|
| 26 |
NCT01605084 |
Withdrawn |
Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone |
|
- Drug: Atazanavir
- Drug: Darunavir
- Drug: Ritonavir
- Drug: Optimized NRTI backbone
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL
- Proportion of subjects with HIV-1 RNA < 50 c/mL
- Change from baseline in CD4 cell count
- (and 3 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01605084 |
AI424-493
2011-006186-18 |
SUPPRESS |
June 2012 |
August 2014 |
August 2014 |
May 24, 2012 |
December 4, 2012 |
|
- Southwest Center For Hiv/Aids
Phoenix, Arizona, United States - Health For Life Clinic Pllc
Little Rock, Arkansas, United States - Uc Davis Medical Center
Sacramento, California, United States - (and 8 more...)
|
| 27 |
NCT01622790 |
Completed |
Evaluation of the Bioequivalence of a Combined Formulated Tablet |
- Infection, Human Immunodeficiency Virus
|
- Drug: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg
- Drug: Dolutegravir 50 mg
- Drug: abacavir 600 mg/lamivudine 300 mg
|
Interventional |
Phase 1 |
- ViiV Healthcare
- Shionogi
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Plasma DTG(dolutegravir), ABC (Abacavir) and 3TC(Lamivudine) PK(Pharmacokinetic) parameters, Area under the concentration-time curve from time zero (pre-dose)
- • Safety and tolerability parameters as assessed by change from baseline in 12-lead ECG and vital signs (BP and HR), number of subjects with adverse events and toxicity grading of clinical laboratory tests.
- Plasma DTG, ABC and 3TC PK parameters tlag, tmax, t½, Terminal elimination phase rate constant, %AUCex, CL/F and Vz/F, and DTG C24
|
66 |
All |
18 Years to 55 Years (Adult) |
NCT01622790 |
114580 |
|
June 2012 |
August 2012 |
August 2012 |
June 19, 2012 |
October 15, 2012 |
|
- GSK Investigational Site
Overland Park, Kansas, United States
|
| 28 |
NCT01608269 |
Completed |
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy |
|
- Drug: Abacavir/Lamivudine
|
Interventional |
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
30 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01608269 |
101-002 |
EPZSwitch |
November 2010 |
October 2012 |
October 2012 |
May 31, 2012 |
April 28, 2017 |
|
- Therapeutic Concepts, PA
Houston, Texas, United States
|
| 29 |
NCT01612169 |
Completed |
Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users |
- HIV
- AIDS
- Substance Abuse
- Inpatient
|
- Behavioral: Patient Navigation (PN) Group
- Behavioral: Patient Navigator Plus Contingency Management (PN+CM) Group
|
Interventional |
Not Applicable |
- Columbia University
- Jackson Health System
- Grady Health System
- (and 10 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HIV Viral Suppression
- HIV Secondary Outcomes
- Substance Use Related Secondary Outcomes
- Mediators and Moderators of Outcomes
|
801 |
All |
18 Years and older (Adult, Senior) |
NCT01612169 |
AAAK1709
U10DA013720-11 |
CTN0049 |
July 2012 |
June 2015 |
June 2015 |
June 5, 2012 |
March 14, 2016 |
|
- University Hospital At University of Alabama, Birmingham (Uab)
Birmingham, Alabama, United States - Los Angeles County Harbor-UCLA Medical Center
Torrance, California, United States - Jackson Memorial Hospital
Miami, Florida, United States - (and 9 more...)
|
| 30 |
NCT01620073 |
Completed |
Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy |
- Male Partner
- HIV Counseling and Testing
- Home Based
- Pregnancy
|
- Other: HIV counseling and testing
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Prevention
|
- Number of Male Partners Counseled and Tested for HIV During Pregnancy
|
488 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01620073 |
42561 |
|
July 2012 |
July 2013 |
July 2013 |
June 15, 2012 |
August 28, 2013 |
|
- Ahero Sub-District Hospital, Nyando, Kenya
Kisumu, Nyanza, Kenya - Ahero Sub-District Hospital
Kisumu, Nyanza, Kenya
|
| 31 |
NCT01610427 |
Completed |
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects |
|
- Procedure: Blood sample collection
|
Interventional |
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of viable lymphocytes in the CMI samples post-overnight intracellular cytokine staining (ICS) for each combination of "time-to-process" (2h, 7h, 24h) and "resting time" (2h, 6h, 18h)
- Number of viable lymphocytes in the CMI samples post-overnight ICS for each combination of "time-to-process" (2h, 7h, 24h), and "resting time" of 0h
- Magnitude of HIV-1 specific CD40L+ CD4+ and/or CD8+ T cell responses in the CMI samples post-overnight ICS expressing at least one cytokine after stimulation for each combination of "time-to-process" (2h, 7h, 24h) and "resting time" (0h, 2h, 6h, 18h)
- (and 2 more...)
|
22 |
All |
18 Years to 55 Years (Adult) |
NCT01610427 |
116329 |
|
June 2012 |
October 2012 |
October 2012 |
June 4, 2012 |
October 13, 2014 |
|
- GSK Investigational Site
Gent, Belgium
|
| 32 |
NCT01611402 |
Completed |
Gene Expression in HIV and Tuberculosis Co-infection |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Identify blood mRNA expression profiles distinguishing TB onoinfectedfrom TB/HIV co-infected patients (ART-naive and ART-treated with and without TB-IRIS).
- Correlate gene expression levels with clinical and laboratory variablesincluding flow cytometry and soluble biomarkers.
- Quantify the tuberculosis antigen load at the beginning of anti-TB therapy by lateral flow lipo-arabinomannan assay (TB-LAM LFA) and study how the antigen burden affects the disease presentation (including radiographic findings), or transcriptio...
- Study separated cell populations (monocytes, dendritic cells, NK, T cell subsets or neurtrophils) to validate any identified transcriptional signature or to further investigate pathogen-specific responses.
|
96 |
All |
18 Years and older (Adult, Senior) |
NCT01611402 |
120142
12-I-0142 |
|
May 29, 2012 |
|
April 6, 2016 |
June 5, 2012 |
April 5, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 33 |
NCT01614249 |
Completed
Has Results |
Omega-3 Supplementation and Depression Clinical Trial |
|
- Dietary Supplement: Soybean oil soft gels
- Dietary Supplement: Fish oil omega-3 EPA-rich soft gels
|
Interventional |
Phase 2
Phase 3 |
- University of Nairobi
- Consortium for Advanced Research Training in Africa (CARTA)
- Innovix Pharma Inc.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Change in BDI-II Depressive Symptom Scores
|
216 |
Female |
15 Years to 49 Years (Child, Adult) |
NCT01614249 |
ODR-2011/2012
ECCT/12/03/01 |
|
June 2012 |
July 2013 |
January 2014 |
June 7, 2012 |
March 8, 2016 |
March 8, 2016 |
- Nairobi City Council Health Facilities
Nairobi, Kenya
|
| 34 |
NCT01619527 |
Completed |
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions |
|
- Drug: darunavir
- Drug: cobicistat
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Comparison of maximum plasma analyte concentration (Cmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
- Comparison of last observed measurable analyte concentration (Clast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
- Comparison of actual sampling time to reach the maximum plasma analyte concentration (tmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
- (and 5 more...)
|
133 |
All |
18 Years to 60 Years (Adult) |
NCT01619527 |
CR100699
TMC114IFD1003
2012-000273-23 |
|
April 2012 |
August 2012 |
August 2012 |
June 14, 2012 |
March 4, 2013 |
|
|
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