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NCT02440789 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)
A Phase 1 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 10
- Study locations
NCT02440789: Completed Phase 1 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT02440789 is a Phase 1 study of HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 32 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02440789, a Phase 1 study of HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes the level of HIV in the participants' blood; and how sirolimus interacts with ART in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus had also been used for the prevention of complications after stem cell transplants and as a treatment for certain kinds of cancers in HIV-infected patients.
Primary Outcome
The study-defined primary safety endpoint was a composite endpoint. A participant was considered to have met the endpoint if the participant 1) experienced a new Grade ≥3 Adverse Event (AE), including signs/symptoms, lab toxicity or clinical event, that was definitely, probably or possibly related to study treatment, as judged by the core team, or 2) had a change in CD4+ cell count ( confirmed \>50% decline or to \<300 cells/mm3) while on sirolimus. The screening visit occurred within 60 days of
Conditions Studied
Interventions
- DRUG Sirolimus
Study Locations (10)
New York
- Weill Cornell Uptown CRS (7803) - New York
- 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS - Rochester
California
- 801 University of California, San Francisco HIV/AIDS CRS - San Francisco
District of Columbia
- Whitman Walker Health CRS (31791) - Washington D.C.
Florida
- Univ. of Miami AIDS CRS (901) - Miami
Georgia
- The Ponce de Leon Center CRS (5802) - Atlanta
Missouri
- Washington University CRS (2101) - St Louis
Ohio
- Univ. of Cincinnati CRS (2401) - Cincinnati
Texas
- Houston AIDS Research Team CRS (31473) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-12-21 |
| Est. Completion | 2018-02-01 |
| Phase | Phase 1 |
What the finished NCT02440789 record still lists
NCT02440789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (91% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.
NCT02440789 lists 10 locations in 9 states (New York, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT02440789 about?
NCT02440789 is a clinical study titled "Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)". The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes the level of HIV in ...
What is the current status of trial NCT02440789?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-12-21. Estimated completion is 2018-02-01.
What conditions does trial NCT02440789 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT02440789?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT02440789?
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.
Where is trial NCT02440789 being conducted?
This trial has 10 study locations across California, District of Columbia, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02440789's enrollment target sits among peer trials
32 57th of 71 higher than 15 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
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