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

July 30, 2021 updated by: AIDS Clinical Trials Group

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study was conducted with an initial lead-in period of 12 weeks where participants remained on ART, without study intervention. Samples were collected to define the pre-intervention steady-state of HIV, inflammation and immune activation parameters.

At week 12, sirolimus therapy was initiated for the planned 20 weeks of treatment. In order to achieve therapeutic levels, sirolimus therapy was initiated with lead-in dose of 0.025 or 0.05 mg/kg/day, depending on the ART regimen. Doses for each participant were then adjusted, based on trough blood sirolimus concentrations, to achieve target concentrations between 5 and 10 ng/mL. There were frequent initial visits for sirolimus trough concentration monitoring and potential dose adjustments, at weeks 12.5, 13, 13.5, 14, 14.5, 15, 15.5 and 16. Then visits occurred at weeks 18, 20, 24, 28 and 32. After the week 32 visit, the planned end of study treatment, there was an additional 12 weeks of post-sirolimus follow-up, with a final visit at week 44.

Study visits included physical examinations, clinical assessments, safety monitoring, and blood and oral swab collection. Anal swabs were collected at week 12 and 32. Samples were stored for subsequent protocol testing for the study outcomes.

In the primary analysis, the significance level was 0.05 for all analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • 801 University of California, San Francisco HIV/AIDS CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20005
        • Whitman Walker Health CRS (31791)
    • Florida
      • Miami, Florida, United States, 33136
        • Univ. of Miami AIDS CRS (901)
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • The Ponce de Leon Center CRS (5802)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University CRS (2101)
    • New York
      • New York, New York, United States, 10011
        • Weill Cornell Uptown CRS (7803)
      • Rochester, New York, United States, 14642
        • 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Univ. of Cincinnati CRS (2401)
    • Texas
      • Houston, Texas, United States, 77030
        • Houston AIDS Research Team CRS (31473)
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington AIDS CRS (1401)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-1 infection
  • On continuous ART for ≥24 months prior to study entry.
  • CD4+ cell count ≥350 cells/mm^3
  • Plasma HIV-1 RNA below the level of quantification for ≥24 months.
  • White blood cell (WBC) ≥3000/mm^3
  • Platelet count ≥125,000/mm^3
  • Absolute neutrophil count (ANC) >1300/mm^3
  • Aspartate aminotransferase (AST) <1.25 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) <1.25 x ULN
  • Calculated creatinine clearance (CrCl) ≥60 mL/min
  • Fasting or non-fasting triglyceride level ≤350 mg/dL
  • Fasting or non-fasting LDL <160 mg/dL
  • Urine protein to urine creatinine ratio ≤1 g/g from random urine collection

Exclusion Criteria:

  • Serious illness requiring systemic treatment and/or hospitalization
  • Documentation of any CDC Category C AIDS-indicator condition or oropharyngeal candidiasis (thrush)
  • Intended modification of ART during the study.
  • Latent tuberculosis (TB) infection
  • TB disease within 48 weeks prior to study entry requiring treatment.
  • History of active hepatitis B (HBV) infection.
  • Hepatitis C virus (HCV) RNA-positive
  • Previous myelodysplasia syndrome, lymphoproliferative disease, lung disease, malignancies, congestive heart failure, life-threatening fungal infection or herpes-zoster/varicella-zoster viral infection requiring treatment.
  • Detectable Epstein-Barr virus (EBV) in blood
  • Active infection other than HIV that required receipt of systemic antibiotic therapy by intravenous infusion
  • History of major hypersensitivity reaction to macrolide drugs including angioedema, anaphylaxis, drug-induced dermatitis, or hypersensitivity vasculitis.
  • Currently pregnant or breastfeeding, or planning to become pregnant prior to or during the study.
  • Use of immunomodulators (eg, interleukins, interferons, and cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy.
  • Active drug or alcohol use or dependence
  • Vaccination within 14 days prior to study entry.
  • On or planned to change to a PI-based ART or cobicistat-boosted regimen
  • Anti-human papillomavirus (HPV) therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sirolimus
Drug: Sirolimus

Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Met the Study-defined Composite Safety Endpoint
Time Frame: Screening to study week 32 (week 20 of Sirolimus)
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 study entry.
Screening to study week 32 (week 20 of Sirolimus)
Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Frequency of HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
CD4+ T-cell-associated HIV-1 RNA. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in CD4+ T-cell-associated HIV-1 RNA (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Plasma HIV-1 RNA by SCA
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Plasma HIV-1 RNA by SCA
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Change in plasma HIV-1 RNA by SCA (week 32 measurement minus baseline measurement).

Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of CD4+ T-cell Counts
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
CD4+ T-cell counts. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in CD4+ T-cell Counts
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 RNA Levels
Time Frame: weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44
HIV-1 RNA levels by conventional assay
weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44
Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
HIV-1 DNA levels in CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in HIV-1 DNA levels in CD4+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %CD69+ CD4+ T-cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Measurement of %CD69+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %CD69+ CD4+ T-cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %CD69+ CD8+ T-cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Measurement of %CD69+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %CD69+ CD8+ T-cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %Ki67+ CD4+ T-cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Measurement of %Ki67+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %Ki67+ CD4+ T-cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement).
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %Ki67+ CD8+ T-cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Measurement of %Ki67+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %Ki67+ CD8+ T-cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %PD1+ CD4+ T-cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Measurement of %PD1+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %PD1+ CD4+ T-cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %PD1+ CD8+ T-cells
Time Frame: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Measurement of %PD1+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).
At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %PD1+ CD8+ T-cells
Time Frame: At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement)
At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AIDS Clinical Trials Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Timothy Henrich, MD, University of California, San Francisco
  • Study Chair: Priscilla Hsue, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

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Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACTG A5337
  • 2UM1AI068636 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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