Overview

Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies. About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery. There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery. The proposed NVP schedule is simpler and possibly could be used in Uganda.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Nevirapine
Zidovudine
Criteria
Inclusion Criteria

Mothers may be eligible for this study if they:

- Have been pregnant for more than 32 weeks and are at least 18 years of age.

- Are HIV-positive.

- Reside within 15 km of Mulago Hospital, the study site.

- Infants may be eligible for this study if they:

- Are born to mothers enrolled in the study.

- Have consent of the mother/guardian and, if available, the father.

Exclusion Criteria

Mothers will not be eligible for this study if they:

- Have a serious infection or illness other than HIV.

- Currently take any anti-HIV drugs.

- Participate during this pregnancy in another treatment vaccine perinatal trial.

- Received NVP or AZT within the last 6 months.

- Are allergic to any benzodiazepine.

- Abuse alcohol or other drugs.

- Have high blood pressure that is not controlled.

- Have received any anticoagulants, benzodiazepines other than the study drug, or
magnesium sulfate within 2 weeks before being assigned to a study group or delivery.

- Infants will not be eligible for this study if:

- Their mother is excluded prior to being assigned to a study group.