HIV/AIDS
Conditions
Interventions
CAB LEN
Sponsors
Africa Clinical Research Network
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnancy and HIV diagnosis Pregnant woman aged =18 years (or =16 years where the country-specific appendix authorises; see country appendices). Confirmed intrauterine pregnancy by transabdominal ultrasound prior to randomisation. Gestational age 14–32 weeks (inclusive) at randomisation, dated by best-obstetric-estimate. Confirmed HIV-1 infection per the protocol-specified diagnostic algorithm. Detectable plasma HIV-1 RNA at screening, defined as HIV-1 RNA =50 copies/mL by central-laboratory assay reviewed before Day 0 randomisation. (Qualified point-of-care viral-load platforms may be used for internal triage or QC but do not replace central confirmation for randomisation.) ART history ART-naive first-time HIV diagnosis at the antenatal-entry visit, OR no prior antiretroviral exposure documented in clinic records or self-report; OR Previously on ART but off ART for =28 calendar days at the time of screening, regardless of reason for prior discontinuation. Prior virologic failure does not disqualify. Capacity and consent Willing and able to provide informed consent (or assent with co-consent per the country-specific appendix for ages 16–17 where applicable). Willing to attend study visits and complete contacts per the Schedule of Activities, including the Day -3, Day 0, Day +1, Day +7, and Day +14 initiation-period requirements where applicable. Willing to receive long-acting injections (CAB intramuscular and LEN subcutaneous) if randomised to the investigational arm.
Exclusion criteria
Exclusion criteria: Active opportunistic infection requiring inpatient care or systemic therapy at screening. Known hypersensitivity to cabotegravir, lenacapavir, tenofovir, lamivudine, or dolutegravir. Current use of a prohibited concomitant medication (Section 6.11.1). Grade 3 or higher renal impairment (eGFR 5× upper limit of normal) at screening. Active hepatitis B or hepatitis C infection requiring antiviral therapy that is incompatible with the assigned regimen. Multiple gestation (=2 fetuses) where the obstetric care plan precludes participation in the protocol. Major fetal anomaly identified at the screening or baseline ultrasound that in the investigator's judgement warrants exclusion. Active substance use disorder uncontrolled by treatment that the investigator judges incompatible with safe study participation. Concurrent enrolment in another investigational drug or device trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal virologic suppression (HIV-1 RNA <50 copies/mL) | — |
Secondary
| Measure | Time frame |
|---|---|
| Early MTCT (confirmed infant HIV-1 infection);Cumulative MTCT (confirmed infant HIV-1 infection);Maternal virologic suppression at delivery (descriptive);Maternal and infant safety (AEs/SAEs);Retention in care;Adherence to assigned regimen(composite) | — |
Countries
South Africa, Uganda, Zimbabwe
Contacts
Public ContactRomina Mariano
Chief of Staff Africa Clinical Research Network
Outcome results
None listed