Alendronate for HIV/AIDS
(STAIR-HIV 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either alendronate or placebo while continuing antiretroviral therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alendronate
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor