Study to Improve Survival Among HIV-Exposed Infants in Botswana (Mpepu)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Harvard School of Public Health
Sponsor:
Collaborators:
Harvard Medical School
Information provided by (Responsible Party):
Roger Shapiro, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01229761
First received: October 22, 2010
Last updated: May 22, 2014
Last verified: May 2014

October 22, 2010
May 22, 2014
May 2011
March 2017   (final data collection date for primary outcome measure)
Survival [ Time Frame: 18 months of age ] [ Designated as safety issue: Yes ]
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.
  • Survival [ Time Frame: 18 months of age ] [ Designated as safety issue: Yes ]
    The first 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.
  • HIV-free survival [ Time Frame: 18 months of age ] [ Designated as safety issue: Yes ]
    The second primary outcome measure is HIV-free survival between 4 weeks and 18 months among infants randomized to either 6 months or 12 months of breastfeeding.
Complete list of historical versions of study NCT01229761 on ClinicalTrials.gov Archive Site
  • HIV-free Survival [ Time Frame: 18 months of age ] [ Designated as safety issue: Yes ]
    Secondary outcome measures will evaluate HIV-free survival between 4 weeks and 18 months among infants randomized to either 6 months or 12 months of breastfeeding.
  • Safety of CTX prophylaxis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Secondary outcome measures will evaluate the safety of CTX prophylaxis through 18 months
  • Morbidity and mortality [ Time Frame: 18 months of age ] [ Designated as safety issue: Yes ]
    Secondary outcome measures will evaluate morbidity and mortality to 18 months.
  • Morbidity and mortality [ Time Frame: 18 months of age ] [ Designated as safety issue: Yes ]
    Secondary outcome measures will evaluate morbidity and mortality to 18 months.
  • Safety of CTX prophylaxis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Secondary outcome measures will evaluate the safety of CTX prophylaxis through 18 months
Not Provided
Not Provided
 
Study to Improve Survival Among HIV-Exposed Infants in Botswana
A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Neutropenia
  • Anemia
  • Drug: 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
    Other Name: Trimethoprim-Sulfamethoxazole Combination
  • 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
  • Behavioral: 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.
  • Behavioral: breastfeeding for 12 months
    Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.
  • Active Comparator: infant cotrimoxazole
    Intervention: Drug: cotrimoxazole prophylaxis
  • Placebo Comparator: infant placebo
    Intervention: Drug: cotrimoxazole placebo
  • Active Comparator: exclusive breastfeeding for 6 months
    Intervention: Behavioral: exclusive breastfeeding until 6 months of age
  • Active Comparator: exclusive breastfeeding for 12 months
    Intervention: Behavioral: breastfeeding for 12 months
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3724
July 2017
March 2017   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Gbolahan Ajibola 267-3902671 gajibola@bhp.org.bw
Contact: Kate Powis 267-3902671 kpowis@partners.org
Botswana
 
NCT01229761
18677, R01HD061265
Yes
Roger Shapiro, Harvard School of Public Health
Harvard School of Public Health
  • Harvard Medical School
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Shahin Lockman, MD, MS Harvard School of Public Health
Principal Investigator: Roger L Shapiro, MD, MPH Harvard School of Public Health
Harvard School of Public Health
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP