Trial record 6 of 35 for:    " October 13, 2010":" November 12, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 3724
Study Start Date: May 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2017 (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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229761

Contacts
Contact: Gbolahan Ajibola 267-3902671 gajibola@bhp.org.bw
Contact: Kate Powis 267-3902671 kpowis@partners.org

Locations
Botswana
Princess Marina Hospital Recruiting
Gaborone, Botswana
Athlone Hospital Recruiting
Lobatse, Botswana
Scottish Livingstone Hospital Recruiting
Molepolole, Botswana
Sponsors and Collaborators
Harvard School of Public Health
Harvard Medical School
Investigators
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

No publications provided

Responsible Party: Roger Shapiro, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01229761     History of Changes
Other Study ID Numbers: 18677, R01HD061265
Study First Received: October 22, 2010
Last Updated: May 22, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
Botswana: Health Research and Development Committee
Botswana: Ministry of Health

Keywords provided by Harvard School of Public Health:
HIV
Trimethoprim-Sulfamethoxazole Combination
Breast Feeding
Infant Mortality
Morbidity
Botswana
Africa
Infectious disease transmission, vertical
infant mortality
adverse drug event

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Anemia
Neutropenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014