Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01025427 · ClinicalTrials.gov registry record · Phase 4
HIV Persistence and Viral Reservoirs
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT01025427 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 16 participants.
The verdict
NCT01025427, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it does not to completely restore health. Patients doing well on otherwise effective HAART remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other "non-AIDS-defining" events. While complete eradication may never be feasible, a "functional cure" in which patients are able to maintain undetectable viral loads indefinitely without therapy may be possible. The best evidence for this are the so-called "elite" controllers, whom we define as individuals who are HIV-seropositive, with plasma HIV RNA levels below the level of conventional detection without treatment. Controllers may be conceptualized as a naturally occurring model of a functional cure (or "HIV remission"), and are ideal patients in which to study HIV persistence and the possibility of eradication. We propose to conduct a pilot study to better characterize the reservoirs that lead to viral persistence in a group of well-characterized controllers. We propose two specific aims: 1) to characterize the dynamics of viral production in blood and gut-associated lymphoid tissue (GALT) in controllers; and 2) to prospectively treat 10 controllers with raltegravir, tenofovir/emtricitabine for 24 weeks and study the effects of HAART on viral dynamics and host inflammatory responses. Our primary hypotheses are: 1) viral replication is ongoing in untreated controllers, 2) HAART will reduce viral replication in blood and GALT and decrease immune activation, and 3) higher levels of immune activation are associated with greater measures of microbial translocation and distribution of virus to more differentiated T cell subsets.
Interventions
- DRUG Raltegravir, tenofovir/emtricitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01025427
The ClinicalTrials.gov registry entry for NCT01025427 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Raltegravir, tenofovir/emtricitabine is the first listed.
NCT01025427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01025427 about?
NCT01025427 is a clinical study titled "HIV Persistence and Viral Reservoirs". Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it does not to completely restore health. Patients doing well on otherwise effective HAART remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other "non-AIDS-defining" events. While comple...
What is the current status of trial NCT01025427?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2009-12. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01025427?
The interventions under investigation include: Raltegravir, tenofovir/emtricitabine (DRUG).
Who is sponsoring clinical trial NCT01025427?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.