A5428: Small Trial of Alendronate Impact on the Reservoir of HIV (STAIR-HIV)

HIV Cure, Treatment Experienced

Though antiretroviral therapy (ART) is very effective at suppressing the HIV virus, it is, however, unable to totally remove it from the body because some of the virus hides in places where the ART cannot reach. Once there, the virus slows or stops growing (“falls asleep”) and becomes invisible to the body’s immune system. Scientists are investigating a strategy called “Shock and Kill” to wake up the virus from its resting state so that the body’s immune system can fight the HIV and possibly clear it from the body.

The main purpose of this study is to see how alendronate, a medication that is already U.S. Food and Drug Administration approved for the treatment of osteoporosis, given as a pill once a week, will, after 24 weeks, affect the clearance of HIV that is hiding in the body.

• People living with HIV
• Age 18 to 65 years
• Undetectable HIV viral load
• Taking HIV medication for at least 1 year, but not more than 10 years

At study entry, participants will be randomly assigned (like flipping a coin or rolling dice) to one of two study arms. There will be 20 participants in the alendronate arm and 10 participants in the placebo arm. Everyone in the study will continue to take their ART as provided by their primary care provider.

The study regimen provided will be either alendronate or a pill that looks like alendronate but has no active medicine (placebo).

Participants will be in this study for about 44 weeks; this includes:

• 12 weeks for pre-intervention evaluations
• 24 weeks of study treatment
• 8 weeks of follow-up after stopping study treatment