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NCT01400412 · ClinicalTrials.gov registry record · Phase 2
Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
A Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT01400412: Completed Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT01400412 is a Phase 2 study of HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 262 participants, below the 348-participant average among 71 other HIV-1-infection trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400412, a Phase 2 study of HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the following: * To see how the drug combinations affect the brain and kidneys. * To see how well the drug combinations lower the HIV viral load. * To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.
Primary Outcome
The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Darunavir
- DRUG Tenofovir disoproxil fumarate
- DRUG Emtricitabine
- DRUG Placebo for Tenofovir disoproxil fumarate
Study Locations (20)
California
- University of Southern California (1201) - Los Angeles
- UCLA CARE Center CRS (601) - Los Angeles
- Ucsd, Avrc Crs (701) - San Diego
- Ucsf Aids Crs (801) - San Francisco
Colorado
- University of Colorado Hospital CRS (6101) - Aurora
- University of Colorado Denver ATN CRS (33022) - Denver
District of Columbia
- Georgetown University CRS (GU CRS) (1008) - Washington D.C.
- Children's National Med. Ctr. ATN CRS (33003) - Washington D.C.
Florida
- Univ. of Miami AIDS CRS (901) - Miami
- Univ. of South Florida (USF) College of Medicine ATN CRS (33001) - Tampa
Illinois
- Northwestern University CRS (2701) - Chicago
- Rush Univ. Med. Ctr. ACTG CRS (2702) - Chicago
Maryland
- IHV Baltimore Treatment CRS (4651) - Baltimore
- 201 Johns Hopkins University CRS - Baltimore
Massachusetts
- Massachusetts General Hospital ACTG CRS (101) - Boston
- Brigham and Women's Hosp. ACTG CRS (107) - Boston
Alabama
- 31788 Alabama CRS - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2012-01-17 |
| Est. Completion | 2014-06-30 |
| Phase | Phase 2 |
What the finished NCT01400412 record still lists
NCT01400412 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 348-participant average among 71 other HIV-1-infection trials with a reported enrollment target (25% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which Ritonavir is the first listed.
NCT01400412 names 20 study sites across 11 states, led by California, Colorado, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01400412 about?
NCT01400412 is a clinical study titled "Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen". The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the follo...
What is the current status of trial NCT01400412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2012-01-17. Estimated completion is 2014-06-30.
What conditions does trial NCT01400412 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT01400412?
The interventions under investigation include: Ritonavir (DRUG), Darunavir (DRUG), Tenofovir disoproxil fumarate (DRUG), Emtricitabine (DRUG), Placebo for Tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT01400412?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01400412 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01400412's enrollment target sits among peer trials
262 18th of 71 higher than 54 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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