Understanding HIV interactions during treatment interruptions
Analytic Treatment Interruption in HIV Infection
This study is testing how HIV behaves in people when they take a break from their treatment to see what might cause the virus to come back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04359186 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented HIV infection who have been on ART for at least 12 months and have maintained low viral loads.
Not a fit: Patients who are pregnant, have active hepatitis infections, or significant cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing HIV treatment interruptions and better understanding of viral control.
How similar studies have performed: Other studies have explored treatment interruptions in HIV, but this specific approach focusing on early viral interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.