NCT06908083
Immunologic and Virologic Parameters During Analytical Treatment Interruption Following Combination bNAb Therapy During Suppressive ART
Enrolling by Invitation
PHASE1Ages 18–70InterventionalBasic scienceNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~50 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Analytical Treatment Interruption
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Restart ART
Measured over Week 0 until Week 48 or when participant meets restart criteria
Conditions
Where it's being run
2 sites across 2 statesMaryland1
New York1
Study leadership
- Michael C Sneller, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Condom with spermicide
Diaphragm with spermicide
Contraceptive subdermal implant
Intrauterine device or intrauterine system
Combined estrogen and progestogen oral contraceptive
Injectable progestogen
Contraceptive vaginal ring
Percutaneous contraceptive patches Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant, will be allowed. The documentation of partner sterility can come from the site personnel's review of medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents; 10. Willingness to use barrier protection (male or female) during sexual activity during ATI and until viral re-suppression for those who re-start ART.
Exclusion
Acute myocardial infarction
Acute coronary syndromes
Stable or unstable angina
Coronary or other arterial revascularization procedures
Stroke
Transient ischemic attack
Peripheral arterial disease presumed to be of atherosclerotic origin; 5. Any history of an HIV-associated malignancy, including Kaposi's sarcoma, or any type of lymphoma or virus-associated cancers; 6. Any history of Progressive Multifocal Leukoencephalopathy (PML); 7. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; NOTE: minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) is not exclusionary. 8. Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or isolated positive HBV core antibody or hepatitis C virus RNA (HCV-RNA) in blood; NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible; as are participants with isolated HBcAb who are receiving an ART regimen that do not include tenofovir (TAF or TDF). 9. Pregnancy or lactation; 10. Receipt of cabotegravir-LA IM or rilpivirine-LA IM within 24 months prior to study entry. 11. Documented multiclass antiretroviral drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study; 12. Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count \<1,000 cells/mcl;
Hemoglobin \<10 gm/dL;
Platelet count \<100,000 cells/mcl;
ALT \>1.5 x ULN;
AST \>1.5 x ULN;
Total bilirubin greater than 1.5 x ULN;
eGFR \<60 mL/min/1.73m\^2; 13. Receipt of an investigational product within 12 weeks prior to study entry or expected participation in such a study during this study. 14. Participation in other studies that require frequent blood sample collection during participation in this study. 15. Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.
What this trial measures
- Time to Restart ARTWeek 0 until Week 48 or when participant meets restart criteria
Difference in number of days from stopping ART (Day 0) until participant meets restart criteria between MCA-1034/001037 (NIH) bNAb and placebo recipients