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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01777997
The ClinicalTrials.gov registry entry for NCT01777997 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Emtricitabine/rilpivirine/tenofovir disoproxil fumarate is the first listed.
NCT01777997 reports 0 study locations.
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.
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