Alendronate for HIV/AIDS

(STAIR-HIV Trial)

Not yet recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Antiretrovirals
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether alendronate, a drug for bone health, can reduce the HIV-1 reservoir in individuals on antiretroviral therapy (ART). Participants will receive either alendronate or a placebo to determine if the drug affects their HIV levels. This double-blind study ensures that neither participants nor researchers know who receives the actual medication. Individuals who have been on ART for 1 to 10 years, without major treatment breaks, and have stable HIV levels might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in HIV treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications, but you must have been on antiretroviral therapy (ART) for at least a year and should not plan to change your ART regimen during the study.

Is there any evidence suggesting that alendronate is likely to be safe for humans?

Research has shown that alendronate is usually safe for people with HIV. One study found that young people with HIV and low bone strength experienced no safety issues when taking alendronate. Another study discovered that children and teens with HIV tolerated alendronate well for 48 weeks, with no safety problems. These findings suggest that alendronate is safe for people with HIV. However, discussing any possible risks with a healthcare provider before joining a trial is always important.12345

Why do researchers think this study treatment might be promising for HIV?

Researchers are excited about Alendronate for HIV/AIDS because it targets bone density loss, a significant concern for people living with the condition. Unlike standard treatments that focus primarily on managing the virus itself, Alendronate specifically addresses osteoporosis, which is a common issue due to both the disease and its treatments. This drug, typically used for osteoporosis in the general population, offers a new approach by strengthening bones and potentially reducing fracture risks in HIV patients, which is not the main focus of current antiretroviral therapies.

What evidence suggests that alendronate might be an effective treatment for HIV?

Research has shown that alendronate, which participants in this trial may receive, improves bone strength in people with HIV who are taking antiretroviral therapy (ART). In past studies, HIV patients using alendronate demonstrated better bone density over time. This is crucial because people with HIV often experience bone loss. Although this trial examines alendronate's effect on the HIV-1 reservoir, current evidence supports its positive impact on bone health in this group. While direct evidence of its effect on the HIV-1 reservoir is not yet available, alendronate's benefits for bone density are well-documented.23467

Are You a Good Fit for This Trial?

This trial is for individuals with HIV/AIDS who are currently on antiretroviral therapy. The study aims to include those interested in whether alendronate can affect the HIV-1 reservoir. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Participants must be able to swallow pills without difficulty
Participants must have a confirmed HIV-1 diagnosis shown by an approved rapid HIV test or HIV enzyme/chemiluminescence test
Participants should not plan to change their ART regimen during the study
See 9 more

Exclusion Criteria

Participants with active cancer, drug/alcohol dependence, or serious illness
I am a male with stable low testosterone and won't change my treatment plan.
I have a condition affecting my esophagus or difficulty swallowing.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either alendronate or placebo while continuing antiretroviral therapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Alendronate
Trial Overview The trial is testing if alendronate, compared to a placebo, has an impact on the HIV-1 reservoir in people already treated with ART. Participants are randomly assigned to receive either alendronate or a placebo without knowing which one they get.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: AlendronateExperimental Treatment1 Intervention
Group II: Arm B: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/22353022/
Effect of alendronate on HIV-associated osteoporosisAlendronate 70 mg weekly for 96 weeks improves BMD in HIV-1-infected patients on antiretroviral therapy. Trial registration: ClinicalTrials.gov NCT00120757.
Optimizing bone health in people living with HIVThis first network meta-analysis of osteoporosis treatments in PLWH found zoledronate-based regimens significantly improved bone mineral density ...
Safety and Effectiveness of Alendronate for Bone Mineral ...HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and ...
Effect of Alendronate on HIV-Associated OsteoporosisThe primary endpoint for efficacy was the percentage change in BMD at the site with a t-score≤−2.5. Forty-four antiretroviral-treated patients (42 men, 2 ...
Alendronate can prevent bone loss in people starting HIV ...A short course of alendronate around the time of starting tenofovir-based antiretroviral therapy can help prevent bone loss, according to a study.
Safety and Efficacy of 48 and 96 Weeks of Alendronate in ...No safety concerns were identified in a randomized, crossover study of alendronate/placebo in youth with perinatal HIV infection and low bone mineral density (
Alendronate Improves Bone Mineral Density in Children ...In this small study in children and adolescents perinatally infected with HIV with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety ...
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