Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
Public ClinicalTrials.gov record NCT01400412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Double-Blind, Placebo-Controlled, Exploratory Randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment-Naïve Patients Infected With R5-Tropic HIV-1
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01400412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 262 participants
Conditions and interventions
Conditions
Interventions
- Darunavir Drug
- Ritonavir Drug
- Tenofovir disoproxil fumarate Drug
- Emtricitabine Drug
- Placebo for Tenofovir disoproxil fumarate Drug
- Placebo for Maraviroc Drug
- Maraviroc Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2012
- Primary completion
- Jun 29, 2014
- Completion
- Jun 29, 2014
- Last update posted
- Oct 14, 2024
2012 – 2014
United States locations
- U.S. sites
- 37
- U.S. states
- 19
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 31788 Alabama CRS | Birmingham | Alabama | 35294 | — |
| University of Southern California (1201) | Los Angeles | California | 90033-1079 | — |
| UCLA CARE Center CRS (601) | Los Angeles | California | 90095 | — |
| Ucsd, Avrc Crs (701) | San Diego | California | 92103 | — |
| Ucsf Aids Crs (801) | San Francisco | California | 94110 | — |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | — |
| University of Colorado Denver ATN CRS (33022) | Denver | Colorado | 80262 | — |
| Georgetown University CRS (GU CRS) (1008) | Washington D.C. | District of Columbia | 20007 | — |
| Children's National Med. Ctr. ATN CRS (33003) | Washington D.C. | District of Columbia | 20010 | — |
| Univ. of Miami AIDS CRS (901) | Miami | Florida | 33136 | — |
| Univ. of South Florida (USF) College of Medicine ATN CRS (33001) | Tampa | Florida | 33606 | — |
| The Ponce de Leon Center CRS (5802) | Atlanta | Georgia | 30308 | — |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | — |
| Rush Univ. Med. Ctr. ACTG CRS (2702) | Chicago | Illinois | 60612 | — |
| IHV Baltimore Treatment CRS (4651) | Baltimore | Maryland | 21201 | — |
| 201 Johns Hopkins University CRS | Baltimore | Maryland | 21205 | — |
| Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hosp. ACTG CRS (107) | Boston | Massachusetts | 02115 | — |
| Washington U CRS (2101) | St Louis | Missouri | 63110 | — |
| Cooper Univ. Hosp. CRS (31476) | Camden | New Jersey | 08103 | — |
| Columbia Physicians and Surgeons CRS (30329) | New York | New York | 10032 | — |
| Trillium Health ACTG CRS (1108) | Rochester | New York | 14642 | — |
| University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) | Rochester | New York | 14642 | — |
| Unc Aids Crs (3201) | Chapel Hill | North Carolina | 27516 | — |
| Moses H. Cone Memorial Hospital CRS (3203) | Greensboro | North Carolina | 27401 | — |
| Univ. of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | — |
| Case CRS (2501) | Cleveland | Ohio | 44106 | — |
| Metro Health CRS (2503) | Cleveland | Ohio | 44109 | — |
| The Ohio State Univ. AIDS CRS (2301) | Columbus | Ohio | 43210 | — |
| Hops. of Univ. of Pennsylvania CRS (6201) | Philadelphia | Pennsylvania | 19104 | — |
| The Miriam Hospital ACTG CRS (2951) | Providence | Rhode Island | 02906 | — |
| St. Jude Children's Research Hosp. ATN CRS (33016) | Memphis | Tennessee | 38105 | — |
| Vanderbilt Therapeutics CRS (3652) | Nashville | Tennessee | 37232 | — |
| Peabody Health Center CRS (31443) | Dallas | Texas | 75215 | — |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | — |
| Texas Childrens Hospital ATN CRS (33018) | Houston | Texas | 77030 | — |
| University of Washington AIDS CRS (1401) | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01400412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01400412 live on ClinicalTrials.gov.