Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant
Nevirapine
+ Nevirapine placebo
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
Study start date: February 1, 2001
Actual date on which the first participant was enrolled.The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well. This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed. A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission. NVP's long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.775 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * HIV infection, documented on two separate specimens * Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height * Permanent residency in Addis Ababa * Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital) * Hemoglobin \>= 7.5 gm/dl within 4 weeks prior to study entry * Serum glutamic pyruvic transaminase (SGPT) \< 5 times upper limit of normal within 4 weeks prior to study entry * Serum creatinine \< 1.5 mg/dl within 4 weeks prior to study entry * Consent form signed by the mother and, when possible, by the father, prior to the onset of labor
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location