Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04359186

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treatment Interruption Arm

Study Details

Brief summary:

The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.

Conditions

HIV/AIDS

Study ID

NCT04359186

Start date

Oct 15, 2020

Status verified date

Jan, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Age >= 18
  • Documented HIV infection
  • Antiretroviral therapy for at least 12 months
  • Screening plasma HIV RNA levels below level of detection (< 40-75 copies/mL), and all available determinations in past 12 months also below level of detection (blips allowed)
  • Screening CD4+ T-cell count >350 cells/uL
  • If of childbearing potential, willing to use two methods of contraception
  • Willing to receive counseling regarding HIV transmission risk mitigation

Exclusion Criteria:

  • Pregnant or plans to become pregnant during the course of the study
  • Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA
  • Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA
  • Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
  • Significant cardiovascular or cerebrovascular disease
  • Recent or prior (within past 5 years) malignancy
  • Severe kidney disease (CrCl < 50 mL/min via Cockroft-Gault method)
  • Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
  • Concurrent treatment with immunomodulatory drugs
  • Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) to prevent HIV transmission with sexual partners not known to be HIV-infected

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment Interruption Arm

Interventions

Treatment Interruption Arm

Individuals with HIV on suppressive ART will interrupt their ART.

Primary outcome measure

  • Acute retroviral syndrome [ Time Frame: Week 0 through Month 6 ]
  • Failure to re-suppress [ Time Frame: Week 0 through Month 12 ]
  • CD4+ T cell decline [ Time Frame: Week 0 through Month 6 ]
  • Time to rebound [ Time Frame: Week 0 through Month 6 ]

Central Contacts and Locations

Central contacts

Steven Deeks, MD

415-476-4082steven.deeks@ucsf.edu

Michael Peluso, MD

415-476-9363michael.peluso@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Rebecca Hoh

rebecca.hoh@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • HIV
  • HIV/AIDS
  • Antiretroviral therapy
  • HIV reservoir
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-23.