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Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

NCT01086878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2011-02-25

No results posted yet for this study

Summary

The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.

Conditions

  • Acquired Immunodeficiency Syndrome
  • Infant, Newborn
  • Anemia
  • Neutropenia
  • HIV Infections

Interventions

DRUG

cotrimoxazole

Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses: * less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim * greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Harvard Initiative for Global Health

    collaborator UNKNOWN

  • The American Society of Tropical Medicine and Hygiene

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Shahin Lockman, MD · Harvard School of Public Health (HSPH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Botswana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086878 on ClinicalTrials.gov