Overview

This trial is active, not recruiting.

Conditions hiv infections, neutropenia, anemia
Treatments cotrimoxazole prophylaxis, cotrimoxazole placebo, exclusive breastfeeding until 6 months of age, breastfeeding for 12 months
Phase phase 2
Sponsor Harvard School of Public Health
Collaborator Harvard Medical School
Start date May 2011
End date March 2015
Trial size 3724 participants
Trial identifier NCT01229761, 18677, R01HD061265

Summary

The purpose of this study is to find ways to improve infant health and survival among infants whose mothers are HIV-infected but who do not themselves have HIV.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
cotrimoxazole prophylaxis Trimethoprim-Sulfamethoxazole Combination
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
(Placebo Comparator)
cotrimoxazole placebo
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
(Active Comparator)
exclusive breastfeeding until 6 months of age
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.
(Active Comparator)
breastfeeding for 12 months
Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.

Primary Outcomes

Measure
Survival
time frame: 18 months of age

Secondary Outcomes

Measure
HIV-free Survival
time frame: 18 months of age
Safety of CTX prophylaxis
time frame: 18 months
Morbidity and mortality
time frame: 18 months of age

Eligibility Criteria

Female participants at least 18 years old.

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 Randomization Only: Women must be willing to breastfeed for up to 12 months, and to stop at 6 months, depending upon their feeding assignment. Exclusion Criteria: - Antepartum women: Known infant anomalies resulting in a high probability that the infant will not survive to 18 months. - Postpartum women: Known HIV-infected infant, or infant medical condition making survival to 18 months unlikely.

Additional Information

Official title A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana
Principal investigator Shahin Lockman, MD, MS
Description As improved MTCT prevention interventions reduce the number of HIV-infected infants in the antepartum and peripartum periods, interventions to improve HIV-free survival among HIV-uninfected infants are needed. Morbidity and mortality are increased among HIV-uninfected infants born to HIV-infected mothers, and reduced infant survival among HIV-exposed infants may lead to as many deaths as HIV infection itself. In Botswana, the use of formula feeding or shorter breastfeeding may worsen the problem of early infant mortality among HIV-exposed infants. The study will enroll pregnant or postpartum HIV-1-infected women, and their HIV-uninfected infants in Botswana. At 2-4 weeks of age, live HIV-uninfected infants will be randomized to receive either double-blinded cotrimoxazole (CTX) or placebo from 2-4 weeks through 15 months. In addition, breastfeeding (BF) infants will be randomized to BF until either 6 or 12 months of age. Children will be followed prospectively until 18 months of age. The primary endpoint will be survival at 18 months comparing all infants in the CTX vs. placebo arms, and by randomized duration of BF among those BF at randomization. Secondary endpoints will evaluate survival and morbidity/mortality at 12 and 15 months; HIV-free survival to 18 months; and the safety of CTX prophylaxis. Secondary observational objectives include comparing MTCT and mortality by initial feeding method (formula feeding or any BF > 1 month), and an analysis of maternal characteristics as predictors for initial feeding choice and HIV-free survival. All women and infants will receive standard antenatal and peripartum prophylaxis from the Botswana government for MTCT prevention (PMTCT), and will choose a feeding method with counseling. Breastfeeding infants will receive infant nevirapine (NVP) prophylaxis or will be protected from MTCT by the use of maternal HAART.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Harvard School of Public Health.