HIVPhase 2STAIR-HIVNCT07216794
Small Trial of Alendronate Impact on the Reservoir of HIV
A Phase 2 study testing Alendronate in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jul 2026to 21 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
- 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.
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- 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.
- Participants must have the following lab values 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. One method must be highly effective (e.g., implant, IUD, oral contraceptives, injectable contraceptives, vaginal ring, contraceptive patch, or sterilization of male partner). The second method must be a barrier method (e.g., condoms, diaphragm, cervical cap, or sponge with spermicide).
- 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. If participants have severe bone thinning (osteopenia), they may need another DEXA scan before joining the study.
- Participants must be able to swallow pills without difficulty.
Who cannot join
- 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).
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Colorado Hospital (Site ID: 6101)
Aurora, Colorado, 80045
Nicola Haakonsen, 303-724-5931, nicola.haakonsen@cuanschutz.edu
- Not yet recruiting
Chapel Hill (Site ID: 3201)
Chapel Hill, North Carolina, 27599
Erin Hoffman, 919-843-0720, erin_hoffman@med.unc.edu
- Recruiting
Ohio State University (Site ID: 2301)
Columbus, Ohio, 43210
Jessica Marburger, 614-293-8112, jessica.marburger@osumc.edu
- Recruiting
University of Pittsburgh (Site ID: 1001)
Pittsburgh, Pennsylvania, 15213
Stacey M. Edick, 412-383-1748, edicksm2@upmc.edu
- Recruiting
University of California, San Francisco HIV/AIDS (Site ID: 801)
San Francisco, California, 94110
Jay Dwyer, 415-502-5748, Jay.Dwyer@ucsf.edu
About this study
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.
- Conditions
- HIV
- Being tested
- Alendronate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
70 mg oral capsules
PlaceboOther
Matching ALN placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Alendronate | Experimental | Not described Receives: Drug: Alendronate |
| Arm B: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intact HIV-1 deoxyribonucleic acid (DNA) copies by the Intact Proviral DNA Assay (IPDA) in peripheral blood
Measured: Baseline to week 24
Secondary outcomes (16)
Amount of ALN excreted after initial dose of ALN
Measured: Over 24 hours
Peripheral blood CD4+ cell-associated (CA) HIV-1 RNA levels (unspliced and multiply spliced species by quantitative polymerase chain reaction [qPCR])
Measured: At Baseline and Weeks 12, 24 and 32
Number of plasma HIV-1 RNA copies [by single copy assay (SCA)]
Measured: At Baseline and Weeks 12, 24 and 32
HIV RNA in the GI tract (RNA scope and spatial immunophenotyping in sigmoidoscopy samples)
Measured: Pre-intervention and Weeks 22-24
Number of intact HIV-1 DNA copies by the IPDA in peripheral blood
Measured: Weeks 2, 12, and 32
HIV DNA in the GI CD4+ and Vdelta1 (Vd1) T cells (DNA scope in sigmoidoscopy samples)
Measured: Pre-intervention and Weeks 22-24
Peripheral blood CD4+ cell-associated (CA) HIV-1 RNA levels (unspliced and multiply spliced species by qPCR)
Measured: At Baseline and Weeks 1 and 2
Number of plasma HIV-1 RNA copies (by SCA)
Measured: At Baseline and Weeks 1 and 2
Frequency of αβ CD8+ cells by flow cytometry
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Phenotype of αβ CD8+ cells by flow cytometry
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Frequency of γδ cells by flow cytometry
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Phenotype of γδ cells by flow cytometry
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Frequency of NK cells by flow cytometry
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Phenotype of NK cells by flow cytometry
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
HIV-specific responses (IFN- γ and GzmB) by Fluorospot
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Presence of plasma markers of inflammation/activation
Measured: Pre-intervention and Weeks 1, 12, 24, and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start8 Jul 2026
- Primary completion26 Mar 2027 (estimated)
- Study completion21 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216794
- Sponsor's protocol ID
- A5428
- Other IDs
- 39123
- Acronym
- STAIR-HIV
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Trial of Alendronate Impact on the Reservoir of HIV
- ClinicalTrials.gov ID
- NCT07216794
- Acronym / sponsor ID
- STAIR-HIV / A5428
- Conditions
- HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 21 May 2027 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Alendronate | Experimental | Drug: Alendronate |
| Arm B: Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
- Participants should not plan to change their ART regimen during the study.
Key exclusion criteria (26 listed)
- 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).
- Participants with severe, uncontrolled reflux that might increase the risk of esophagitis, according to the site investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronate70 mg oral capsules | Drug | Arm A: Alendronate |
| PlaceboMatching ALN placebo oral capsules | Other | Arm B: Placebo |
Primary outcome
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
16 secondary outcomes
Amount of ALN excreted after initial dose of ALN
Time frame: Over 24 hours
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
Number of plasma HIV-1 RNA copies [by single copy assay (SCA)]
Time frame: At Baseline and Weeks 12, 24 and 32
HIV RNA in the GI tract (RNA scope and spatial immunophenotyping in sigmoidoscopy samples)
Time frame: Pre-intervention and Weeks 22-24
Number of intact HIV-1 DNA copies by the IPDA in peripheral blood
Time frame: Weeks 2, 12, and 32
HIV DNA in the GI CD4+ and Vdelta1 (Vd1) T cells (DNA scope in sigmoidoscopy samples)
Time frame: Pre-intervention and Weeks 22-24
Peripheral blood CD4+ cell-associated (CA) HIV-1 RNA levels (unspliced and multiply spliced species by qPCR)
Time frame: At Baseline and Weeks 1 and 2
Number of plasma HIV-1 RNA copies (by SCA)
Time frame: At Baseline and Weeks 1 and 2
Frequency of αβ CD8+ cells by flow cytometry
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Phenotype of αβ CD8+ cells by flow cytometry
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Frequency of γδ cells by flow cytometry
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Phenotype of γδ cells by flow cytometry
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Frequency of NK cells by flow cytometry
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Phenotype of NK cells by flow cytometry
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
HIV-specific responses (IFN- γ and GzmB) by Fluorospot
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Presence of plasma markers of inflammation/activation
Time frame: Pre-intervention and Weeks 1, 12, 24, and 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alendronate in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Soriano-Sarabia, PhD (919-904-9668, nataliasorsar@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.