Understanding HIV interactions during treatment interruptions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the dynamics between HIV and the host when antiretroviral therapy (ART) is temporarily paused. Participants living with HIV will undergo intensive monitoring and sampling before and after stopping their ART, with most resuming treatment within three weeks. Those who have previously controlled their virus will have the opportunity for a longer interruption and less strict criteria for restarting ART. The aim is to identify predictors of viral rebound and better understand early virus replication stages.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Steven Deeks, MD — University of California, San Francisco
• Study coordinator: Steven Deeks, MD
• Email: steven.deeks@ucsf.edu
• Phone: 415-476-4082

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.