Small Trial of Alendronate Impact on the Reservoir of HIV (NCT07216794) | Clinical Trial Compass
RecruitingPhase 2
Small Trial of Alendronate Impact on the Reservoir of HIV
United States30 participantsStarted 2026-07-08
Plain-language summary
This clinical trial is designed to test the effects of alendronate (ALN) on people living with HIV who are already receiving antiretroviral therapy (ART). Participants are randomly assigned in a 2:1 ratio to either receive alendronate or a placebo, and neither the participants nor the researchers know who is receiving the actual treatment. The goal is to see if alendronate can reduce the size and activity of the HIV-1 reservoir in these individuals.
Who can participate
Age range
18 Years – 65 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
. Participants must have a confirmed HIV-1 diagnosis. This can be shown by any approved rapid HIV test or HIV enzyme/chemiluminescence test done at any time before joining the study.
. The diagnosis must be confirmed by one of the following tests: a second different antibody test, quantitative or qualitative HIV-1 RNA PCR, HIV DNA PCR, HIV total nucleic acid test, HIV-1/2 differentiation assay, or Western blot. All tests must use whole blood, serum, or plasma (not dried blood spots) and be FDA-approved if available.
. Participants must have been on ART for at least 1 year before joining the study, with no interruptions longer than 7 consecutive days in the past 48 weeks.
. Participants must have been on ART for no more than 10 years before joining the study.
. Participants should not plan to change their ART regimen during the study.
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
Change in intact HIV-1 deoxyribonucleic acid (DNA) copies by the Intact Proviral DNA Assay (IPDA) in peripheral blood
Timeframe: Baseline to week 24
Trial details
NCT IDNCT07216794
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Participants' CD4 cell count must be at least 350 cells/mm³, measured within 30 days before joining the study, at a certified laboratory.
. Participants' HIV-1 RNA levels must be below 50 copies/mL for the past 48 weeks and for a sample taken within 30 days before joining the study, measured at a certified laboratory.
. Participants must have the following lab values within 30 days before joining the study, measured at a certified laboratory:
Exclusion criteria
. Participants who started antiretroviral therapy (ART) during the early stages of HIV infection.
. Male participants with low testosterone levels (below 250 ng/dL) within 90 days before joining the study, or those with levels between 250-400 ng/dL who plan to start testosterone replacement within 90 days before joining the study.
. Males with stable hypogonadism who have been on the same dose of testosterone treatment for at least 24 weeks can join if they don't plan to change their regimen during the study.
. Participants with current or past conditions that cause esophageal inflammation, ulcers, strictures, or swallowing disorders (e.g., Barrett's esophagus, scleroderma, esophageal strictures, achalasia, or other motility disorders).
. Participants with severe, uncontrolled reflux that might increase the risk of esophagitis, according to the site investigator.
. Participants who had esophagitis within the past year.