NCT04359186

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2020Jun 2028

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

7.1 years

First QC Date

April 20, 2020

Last Update Submit

January 21, 2026

Conditions

HIV/AIDS

Keywords

HIVHIV/AIDSAntiretroviral therapyHIV reservoirBiomarkers

Outcome Measures

Primary Outcomes (4)

  • Acute retroviral syndrome

    The proportion of participants developing acute retroviral syndrome

    Week 0 through Month 6

  • Failure to re-suppress

    The proportion of participants who fail to re-suppress to plasma HIV RNA levels \<50 copies/mL after re-initiating ART

    Week 0 through Month 12

  • CD4+ T cell decline

    The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL

    Week 0 through Month 6

  • Time to rebound

    The time between the treatment interruption and plasma HIV RNA \>200 copies/mL

    Week 0 through Month 6

Study Arms (1)

Treatment Interruption Arm

EXPERIMENTAL
Other: Treatment Interruption Arm

Interventions

Treatment Interruption ArmOTHER

Individuals with HIV on suppressive ART will interrupt their ART.

Treatment Interruption Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Steven Deeks, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Deeks, MD

CONTACT

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

Michael Peluso, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

October 15, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)