Small Trial of Alendronate Impact on the Reservoir of HIV
Part of paid clinical trials in San Francisco, California.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT07216794
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Alendronate — DRUG70 mg oral capsules
- Placebo — OTHERMatching ALN placebo oral capsules
Study Details
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.
Key Dates
- Start date
- Jun 27, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 26, 2027
- Completion
- May 21, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Alendronate
- Placebo Comparator: Arm B: Placebo
Primary Outcome Measure
Change in intact HIV-1 deoxyribonucleic acid (DNA) copies by the Intact Proviral DNA Assay (IPDA) in peripheral blood [ Time Frame: Baseline to week 24 ]
Central Contacts
- Natalia Soriano-Sarabia, PhD919-904-9668
- Carlos Malvestutto, MD, PPH614-366-5405
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco HIV/AIDS (Site ID: 801) | San Francisco | California | 94110 | |
| University of Colorado Hospital (Site ID: 6101) | Aurora | Colorado | 80045 | |
| Chapel Hill (Site ID: 3201) | Chapel Hill | North Carolina | 27599 | |
| Ohio State University (Site ID: 2301) | Columbus | Ohio | 43210 | |
| University of Pittsburgh (Site ID: 1001) | Pittsburgh | Pennsylvania | 15213 |
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