Small Trial of Alendronate Impact on the Reservoir of HIV
ConditionHIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Alendronate
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov