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Study to Improve Survival Among HIV-Exposed Infants in Botswana (Mpepu)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Neutropenia Anemia | Drug: cotrimoxazole prophylaxis Drug: cotrimoxazole placebo Behavioral: exclusive breastfeeding until 6 months of age Behavioral: breastfeeding for 12 months | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Prevention |
| Official Title: | A Randomized Study of Cotrimoxazole Prophylaxis and Longer Breastfeeding Duration to Improve Survival Among HIV-Exposed Infants in Botswana |
- Survival [ Time Frame: 18 months of age ]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.
- HIV-free Survival [ Time Frame: 18 months of age ]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 ]Secondary outcome measures will evaluate the safety of CTX prophylaxis through 18 months
- Morbidity and mortality [ Time Frame: 18 months of age ]Secondary outcome measures will evaluate morbidity and mortality to 18 months.
| Estimated Enrollment: | 3724 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | October 2018 |
| Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: infant cotrimoxazole |
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
|
| Placebo Comparator: infant placebo |
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
|
| Active Comparator: exclusive breastfeeding for 6 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.
|
| Active Comparator: exclusive breastfeeding for 12 months |
Behavioral: breastfeeding for 12 months
Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01229761
| Botswana | |
| Princess Marina Hospital | |
| Gaborone, Botswana | |
| Athlone Hospital | |
| Lobatse, Botswana | |
| Scottish Livingstone Hospital | |
| Molepolole, Botswana | |
| Principal Investigator: | Shahin Lockman, MD, MS | Harvard School of Public Health |
| Principal Investigator: | Roger L Shapiro, MD, MPH | Harvard School of Public Health |
More Information
Additional Information:
| Responsible Party: | Roger Shapiro, Principal Investigator, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01229761 History of Changes |
| Other Study ID Numbers: |
18677 R01HD061265 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | October 22, 2010 |
| Last Updated: | March 9, 2017 |
Keywords provided by Roger Shapiro, Harvard School of Public Health:
|
HIV Trimethoprim-Sulfamethoxazole Combination Breast Feeding Infant Mortality Morbidity |
Botswana Africa Infectious disease transmission, vertical adverse drug event |
Additional relevant MeSH terms:
|
HIV Infections Neutropenia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Trimethoprim |
Trimethoprim, Sulfamethoxazole Drug Combination Sulfamethoxazole Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 23, 2017