Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Alendronate

    Drug

    70 mg oral capsules

  • Placebo

    Other intervention

    Matching ALN placebo oral capsules

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm A: AlendronateExperimental treatment 1 intervention
Group B: Arm B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Amount of ALN excreted after initial dose of ALN

Time frame
Over 24 hours
2

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

Time frame
At Baseline and Weeks 12, 24 and 32
3

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

Time frame
At Baseline and Weeks 12, 24 and 32
4

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

Time frame
Pre-intervention and Weeks 22-24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Source ClinicalTrials.gov
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