Study to Improve Survival Among HIV-Exposed Infants in Botswana

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3724 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections Neutropenia Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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infant cotrimoxazole

Group Type ACTIVE_COMPARATOR

cotrimoxazole prophylaxis

Intervention Type 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

infant placebo

Group Type PLACEBO_COMPARATOR

cotrimoxazole placebo

Intervention Type 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 for 6 months

Group Type ACTIVE_COMPARATOR

exclusive breastfeeding until 6 months of age

Intervention Type 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.

exclusive breastfeeding for 12 months

Group Type ACTIVE_COMPARATOR

breastfeeding for 12 months

Intervention Type BEHAVIORAL

Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.

Interventions

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cotrimoxazole prophylaxis

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

breastfeeding for 12 months

Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.

Intervention Type BEHAVIORAL

Other Intervention Names

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Trimethoprim-Sulfamethoxazole Combination

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No