Combinatorial Therapy to Induce an HIV Remission

Korábbi kezelés

• Subjects receiving a non-nucleoside reverse transcriptase inhibitor
• High-level resistance to both 10-1074 and VRC-07 as defined using the PhenoSense Neutralizing Antibody Assay (Monogram Biosciences).

Más betegség

• 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.
• 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.
• Active hepatitis C (HCV) infection. 10. Presence of significant abnormalities on electrocardiogram. 11. History of potential immune-mediated medical conditions. Individuals with isolated Raynaud's phenomenon or localized disease requiring topical therapy alone will not be excluded.

Egyéb

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study

• 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.