Combinatorial Therapy to Induce an HIV Remission (NCT04357821) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Combinatorial Therapy to Induce an HIV Remission
United States11 participantsStarted 2020-08-01
Plain-language summary
Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).
Who can participate
Age range18 Years – 67 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent.
✓. Age ≤67 years at the time of enrollment for those who started treatment during early infection and \<65 years for those who started treatment during chronic infection.
✓. Documented HIV-1 infection.
✓. On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days within the last 1 year, and on a stable regimen that does not include an non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks, without plans to modify ART during the study period.
✓. Screening plasma HIV RNA levels below the level of quantification on all available determinations in past 24 months.
✓. Screening CD4+ T-cell count ≥ 500 cells/mm3.
Exclusion criteria
✕. Subjects receiving a non-nucleoside reverse transcriptase inhibitor
✕. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
✕. High-level resistance to both 10-1074 and VRC-07 as defined using the PhenoSense Neutralizing Antibody Assay (Monogram Biosciences).
✕. Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers.
✕. 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.
What they're measuring
1
Grade 3 or Greater Adverse Event Count
Timeframe: Week 0 through 102
2
Proportion of Participants Achieving Post-treatment Control
✕. CD4+ T cell nadir \<350 cells/mm3 during the chronic phase of infection (beginning 6 months following the estimated infection date and confirmed on repeat testing).
✕. Active hepatitis B (HBV) infection defined as positive HBV surface antigen test.