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COMPLETED Phase 1

Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)

NCT02440789 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 32 participants
Start Date 2015-12-21
Est. Completion 2018-02-01
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02440789

The ClinicalTrials.gov registry entry for NCT02440789 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 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 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02440789 reports 10 study locations spanning 9 distinct geographic areas — top geographies include New York, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02440789?

The interventions under investigation include: Sirolimus (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02440789?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial