Overview

Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
Treatments:
Ampicillin
Anti-Bacterial Agents
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Metronidazole
Nevirapine
Criteria
Inclusion Criteria

- HIV positive.

- 20 to 24 weeks pregnant.

- Willing to take the planned antibiotic treatment.

- Planning to deliver at 1 of the study sites.

- Willing to come back for follow-up visits for 1 year after the baby is born.

Exclusion Criteria

- Have taken antibiotics, except for syphilis or gonorrhea, within the last 2 weeks.

- Are allergic to penicillin, ampicillin, erythromycin, or metronidazole.

- Have major illnesses, such as diabetes, severe kidney or heart disease, or active
tuberculosis, which might affect the pregnancy.

- Are having major problems with the pregnancy, such as placenta previa, ruptured
membranes, or multiple pregnancy.

- Have a central nervous system disease, such as seizures.

- Are taking anticoagulant drugs.