FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
Public ClinicalTrials.gov record NCT01777997. 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 Prospective, Single-Arm, Open-Label Study to Evaluate the Effect of Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate on T-Cell Activation, Absolute CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir in Treatment-Naïve HIV-1 Controllers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was done with people who were infected with HIV, but did not show any signs of having HIV. They were also feeling well without taking HIV medication and had low or undetectable levels of the virus in the blood. The purpose of this study was to see if taking HIV medication (antiretroviral therapy \[ART\]) would reduce immune activation (a signal that the body is fighting an infection) in people who have HIV, but did not show symptoms. Also this study helped determine how safe the drug was and how well people reacted to the drug. For this study, the following antiretroviral therapy (ART) was be provided in the form of a single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF). These drugs were combined as one tablet which was approved by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV medication provided was one of the recommended treatments for HIV, including people with low viral loads (how much HIV you have in your body) who were taking HIV drugs for the first time. The risks seen with this HIV medication were the same that one would encounter when taking these drugs outside of the study.
Study identification
- NCT ID
- NCT01777997
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 38 participants
Conditions and interventions
Conditions
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
- Apr 25, 2013 (Actual)
- Primary completion
- Feb 19, 2016 (Actual)
- Completion
- Feb 7, 2017 (Actual)
- Last update posted
- Aug 3, 2021
2013 – 2017
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 31788 Alabama CRS | Birmingham | Alabama | 35294 | — |
| 801 University of California, San Francisco HIV/AIDS CRS | San Francisco | California | 94110 | — |
| Whitman Walker Health CRS (31791) | Washington D.C. | District of Columbia | 20009 | — |
| The Ponce de Leon Ctr. 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 | — |
| Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hosp. ACTG CRS (107) | Boston | Massachusetts | 02115 | — |
| University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) | Rochester | New York | 14642 | — |
| Bronx-Lebanon Hosp. Ctr. CRS (31469) | The Bronx | New York | 10457 | — |
| Unc Aids Crs (3201) | Chapel Hill | North Carolina | 27516 | — |
| Moses H. Cone Memorial Hospital CRS (3203) | Greensboro | North Carolina | 27401 | — |
| University of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | — |
| Metro Health CRS (2503) | Cleveland | Ohio | 44109 | — |
| Hosp. of the Univ. of Pennsylvania CRS (6201) | Philadelphia | Pennsylvania | 19104 | — |
| Pitt CRS (1001) | Pittsburgh | Pennsylvania | 15213 | — |
| The Miriam Hosp. ACTG CRS (2951) | Providence | Rhode Island | 02906 | — |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01777997, 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 Aug 3, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01777997 live on ClinicalTrials.gov.