Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cotrimoxazole prophylaxis · 1 trial · 3 indications
The primary outcome measure is survival at 18 months comparing all infants in the CTX vs. placebo arms, and by randomized duration of breastfeeding among those breastfeeding at randomization.
| Arm | Type | Description |
|---|---|---|
| infant cotrimoxazole | ACTIVE_COMPARATOR | - |
| infant placebo | PLACEBO_COMPARATOR | - |
| exclusive breastfeeding for 6 months | ACTIVE_COMPARATOR | - |
| exclusive breastfeeding for 12 months | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| cotrimoxazole prophylaxis | DRUG | 100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months |
| cotrimoxazole placebo | DRUG | 100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months |
| exclusive breastfeeding until 6 months of age | BEHAVIORAL | Breastfeeding for 6 months, followed by formula feeding for 6 month. Breastfeeding infants will be prophylaxed with maternal highly active antiretroviral therapy (HAART) (if available) or with infant nevirapine. |
| breastfeeding for 12 months | BEHAVIORAL | Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine. |
Inclusion Criteria: * HIV-infected women, \> 26 weeks gestation and \< 34 days postpartum. * Women must be ¬\> 18 years of age and willing/able to sign informed consent. * Women and infants must be able to follow up regularly at a study clinic through 18 months postpartum. * For Feeding Randomizati...
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