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NCT01777997 · ClinicalTrials.gov registry record · Phase 4
FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
A Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT01777997: Completed Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT01777997 is a Phase 4 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01777997, a Phase 4 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Mean change from baseline (pre-ART \[study entry\] and week 0 on ART \[study week 12\]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE)
Interventions
- DRUG Emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-04-25 |
| Est. Completion | 2017-02-07 |
| Phase | Phase 4 |
What the finished NCT01777997 record still lists
NCT01777997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Emtricitabine/rilpivirine/tenofovir disoproxil fumarate is the first listed.
NCT01777997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01777997 about?
NCT01777997 is a clinical study titled "FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir". 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 ...
What is the current status of trial NCT01777997?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2013-04-25. Estimated completion is 2017-02-07.
What interventions are being tested in trial NCT01777997?
The interventions under investigation include: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT01777997?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01777997's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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