HIV study: Alendronate
Official title Small Trial of Alendronate Impact on the Reservoir of HIV
ClinicalTrials.gov ID: NCT07216794
What this study is testing
What is Alendronate?
An investigational oral medication being studied to see if it can reduce the size and activity of the HIV‑1 reservoir in people living with HIV.
Also referred to as Fosamax.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether alendronate can lower the size and activity of the HIV‑1 reservoir in people already taking antiretroviral therapy.
- Who it's for
- Adults living with HIV who are currently on antiretroviral therapy.
- What's involved
- Participants are randomly given either alendronate tablets or a placebo, and neither they nor the researchers know which they receive.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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...
- 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...
- 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.
You likely can't join 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...
- 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...
- Participants with current or past conditions that cause esophageal inflammation, ulcers, strictures, or swallowing disorders (e.g., Barrett's...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
- 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
- Estimated glomerular filtration rate (eGFR) ≥ 35 mL/min/1.73 m²
- Negative hepatitis B surface antigen (HBsAg)
- Negative hepatitis C antibody or RNA test
- Calcium level between 8.4 mg/dL and 10.6 mg/dL
- Phosphate level ≥ 3.4 mg/dL
- If participants are women who could become pregnant, they must have a negative pregnancy test within 48 hours before joining the study. This test must be done at a certified clinic or laboratory.
- If participants are women who could become pregnant and are sexually active, they must agree to use two methods of contraception from 10 days before starting the study until the end of the study.
- Participants must have a Karnofsky performance score of at least 70 within 90 days before joining the study.
- If participants are postmenopausal women or men aged 50 or older, they must have a DEXA scan within 2 years before joining the study to check for osteoporosis.
- Participants must be able to swallow pills without difficulty.
What rules you out
- 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...
- 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...
- 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.
- Participants who had invasive dental procedures within the past 6 weeks or plan to have them within the next 40 weeks (regular dental cleanings are allowed).
- Participants with significant active periodontal or other pre-existing dental disease at the time of joining the study.
- Participants who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
- Participants who used oral complementary or alternative medicines (herbal and homeopathic products) within the past 14 days.
- Participants who used bisphosphonates (oral or injectable) within the past 12 months.
- Participants with known allergies or sensitivities to ALN, the components of the tablet, or bisphosphonate compounds.
- Participants with active drug or alcohol use or dependence that would interfere with adherence to study requirements, according to the site investigator.
- Participants with acute or serious illness requiring systemic treatment and/or hospitalization within the past 90 days.
- Participants who received any investigational vaccine within the past 180 days or any vaccine within the past 14 days.
- Participants who received anti-HIV broadly neutralizing antibody therapy within the past 78 weeks.
- Participants who received a latency-reversing agent within the past 12 months, unless reviewed and approved by the A5428 Clinical Management Committee (CMC).
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Aurora, Colorado, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Aurora, Colorado, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.