Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02369406 | Early Infant HIV Treatment in Botswana | PHASE2 | ACTIVE NOT_RECRUITING | 67 | — | — | May 4, 2015 | Jun 30, 2029 | Feb 23, 2026 | 1 | Botswana |
Virologic outcomes after early ART: We will evaluate how the timing of HIV infection and the timing of ART initiation affect the size and composition of the viral reservoir over time. Immunologic outcomes after early ART: We will evaluate how immune activation and immune activity against HIV-1 contribute to the size and composition of the HIV-1 reservoir over time in infants treated early with suppressive ART. Control Group Comparisons. We will evaluate virologic and immunologic outcomes at a single time point in children for whom ART initiation was later than in the prospective cohorts, and compared with immunologic testing of stored specimens from HIV exposed uninfected and HIV unexposed children.
| Arm | Type | Description |
|---|---|---|
| Antepartum Cohort | EXPERIMENTAL | 40 children who test HIV-positive within 96 hours after birth (antepartum HIV infection) and are able to initiate ART \< 7 days after birth. This cohort will include at least 15 children who start ART \< 3 days after birth. All infants in the antepartum cohort will initiate ART with Nevirapine, Zidovudine, Lamivudine, and later switch to Kaletra, Zidovudine, Lamivudine. |
| Peripartum Cohort | EXPERIMENTAL | 10 children who test HIV-negative within 96 hours after birth but test HIV-positive \<57 days after birth (peripartum HIV infection) and who are able to initiate ART \<57 days after birth. This cohort will include at least 10 children who start ART \< 21 days after birth. The majority of infants in the peripartum cohort will be able to start Kaletra, Zidovudine, Lamivudine as their first regimen, but a minority may start Nevirapine, Zidovudine, Lamivudine and then switch to Kaletra, Zidovudine, Lamivudine. |
| Control Cohort | NO_INTERVENTION | 25 HIV-infected children who initiated ART at later age ranges (30-365 days for antepartum infection, 57-365 days for peripartum infection or for those with unknown timing of infection) will be enrolled for a single visit that will occur between 24 and 36 months of age. These children will serve as a control group for virologic and immunologic comparisons with children in the prospective cohorts. |
| Name | Type | Description |
|---|---|---|
| Nevirapine | DRUG | - |
| Kaletra | DRUG | - |
| Lamivudine | DRUG | - |
| Zidovudine | DRUG | - |
Inclusion Criteria (antepartum infection cohort): 1. Mother/guardian ≥18 years of age and able to provide informed consent 2. Gestational age at birth ≥35 weeks 3. Birth weight ≥2000 grams 4. Age is less than 7 days\* 5. HIV-infection identified by testing conducted within 96 hours after birth NOTE...