Pausing Antiretroviral Treatment Under Structured Evaluation
Botswana, Malawi, South Africa32 participantsStarted 2024-05-28
Plain-language summary
The main purpose of this study is to see if it is safe to give the study antibodies (3BNC117-LS-J and 10-1074-LS-J) by intravenous infusion to people with HIV (PWH), and to see if they cause any side effects. In addition, to see how the study antibodies affect the level of HIV in the blood when participants are not taking regular HIV treatment for an extended period. This extended period of not taking regular HIV treatment is called an analytical treatment interruption (ATI).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Step 1:
* Ability and willingness of participant to provide informed consent.
* HIV-1 infection, documented by:
* Any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry AND
* Confirmed by one of the following:
* A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used)
* HIV-1 antigen, or
* Plasma HIV-1 RNA viral load, or
* A licensed Western blot \[NOTE: The term "licensed" refers to a U.S. FDA-approved kit.\]
* On stable suppressive ART for at least 96 weeks prior to study entry. \[NOTE: ART interruptions of up to 7 days occurring ≥90 days prior to study entry are acceptable. Within- and between-class changes in ART within the year prior to study entry are acceptable.\]
* Plasma HIV-1 RNA levels of \<50 copies/mL for at least 96 weeks prior to study entry at any licensed local laboratory or Network-approved non-US laboratory that is VQA certified.
\[NOTE: Two "blips" (i.e., plasma HIV-1 RNA \>50 and \<400 copies/mL) are allowed if each blip is preceded and followed by values \<50 copies/mL. At least one viral load measurement in greater than 56 days and within 48 weeks prior to the entry visit and another viral load within 56 days prior to the entry visit must be available for review. \]
* CD4+ cell count \>450 cells/µL obtained within 56 days prior to study en…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of a Grade ≥3 or higher systemic AE or any AE (regardless of grade) leading to premature study or treatment discontinuation
Timeframe: Step 1 Entry (Day 0) through to 48 weeks
2
Viral suppression
Timeframe: Step 1 Entry (Day 0) through to Week 24
Trial details
NCT IDNCT06031272
SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections