Small Trial of Alendronate Impact on the Reservoir of HIV

NCT07216794 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: A542839123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in intact HIV-1 deoxyribonucleic acid (DNA) copies by the Intact Proviral DNA Assay (IPDA) in peripheral blood

  Baseline to week 24

Secondary Outcomes (16)

• Amount of ALN excreted after initial dose of ALN

  Over 24 hours

• Peripheral blood CD4+ cell-associated (CA) HIV-1 RNA levels (unspliced and multiply spliced species by quantitative polymerase chain reaction [qPCR])

  At Baseline and Weeks 12, 24 and 32

• Number of plasma HIV-1 RNA copies [by single copy assay (SCA)]

  At Baseline and Weeks 12, 24 and 32

• HIV RNA in the GI tract (RNA scope and spatial immunophenotyping in sigmoidoscopy samples)

  Pre-intervention and Weeks 22-24

• Number of intact HIV-1 DNA copies by the IPDA in peripheral blood

  Weeks 2, 12, and 32

Study Arms (2)

Arm A: Alendronate

EXPERIMENTAL

Drug: Alendronate

Arm B: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Alendronate DRUG

70 mg oral capsules

Arm A: Alendronate

Placebo OTHER

Matching ALN placebo oral capsules

Arm B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• White blood cells (WBC) ≥ 2,500 cells/mm³
• Absolute neutrophil count (ANC) \> 1,000 cells/mm³
• Hemoglobin \> 12 g/dL for males and \> 11.5 g/dL for females
• Platelet count ≥ 125,000 cells/mm³
• Liver enzymes (AST, ALT, alkaline phosphatase) \< 1.5 times the upper limit of normal (ULN)
• Total bilirubin \< 1.5 times ULN
• Vitamin D level \> 15 ng/mL

You may not qualify if:

• 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.
• Participants with a history of Paget's disease.
• Participants with a history of osteoporosis.
• Participants who had a bone fracture within the past 180 days.
• Participants who had one or more bone fractures not caused by trauma since age 18.
• Participants with diagnosed bleeding disorders or those currently taking anticoagulants or blood factor products.
• Participants who cannot stand up or sit upright for at least 30 minutes.
• Participants who used systemic glucocorticoids for more than 30 days within the past 180 days at doses higher than or equivalent to 7.5 mg prednisone/day or 30 mg hydrocortisone/day.
• Participants with active or recent cancer requiring chemotherapy, immunotherapy, or surgery within the past 36 months or expected to need such treatments in the next year.
• Participants with advanced liver disease (non-alcoholic fatty liver disease, steatohepatitis, or alcoholic liver disease) with known or suspected cirrhosis or fibrosis score ≥F3.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

University of California, San Francisco HIV/AIDS (Site ID: 801)

San Francisco, California, 94110, United States

Location

University of Colorado Hospital (Site ID: 6101)

Aurora, Colorado, 80045, United States

Location

Chapel Hill (Site ID: 3201)

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University (Site ID: 2301)

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh (Site ID: 1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Alendronate

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 15, 2025
• Study Start: January 17, 2026
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): May 21, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.
• Access Criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections). * For what types of analyses? To achieve aims in the proposal approved by the ACTG. * By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

Locations

US (5)