Overview

Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand

Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine (NVP) given to pregnant women at onset of labor and to their infant 48-72 hours after birth in addition to standard oral zidovudine (ZDV or AZT) prophylaxis for the prevention of mother-to-child transmission of HIV-1.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborators:
ANRS, Emerging Infectious Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Harvard School of Public Health
Harvard School of Public Health (HSPH)
Treatments:
Nevirapine
Criteria
Pre-Entry Criteria

Women were eligible for the study if they:

- have evidence of HIV infection (documented by two HIV antibody tests on two different
dates);

- were to be provided ZDV Prophylaxis (starting at 28 weeks or as soon as possible
thereafter);

- intended to carry the pregnancy to term;

- intended to deliver at and bring their infant to a study site for at least 12 months
after delivery; and

- could provide informed consent.

Inclusion criteria

Women are eligible for the study if they:

- met all pre-entry criteria;

- agreed not to breastfeed;

- consented to participate and to be followed for the duration of the study;

- presented the following laboratory values within 14 days prior to randomization:

- hemoglobin > 8.0 mg/dl

- absolute neutrophil count > 1000 cells/mm3

- platelets > 100,000 cells/mm3

- serum creatinine < 1.5 mg/dl (women with a serum creatinine > 1.5 mg/dl must have a
measured eight-hour urine creatinine clearance > 70 ml/min)

- SGPT less than 10 times the upper limit of normal NOTE: Women with a Grade 2 or Grade
3 SGPT value (between 2.6 and 10 times the upper limit of normal) were allowed on
study; they were monitored monthly until delivery. If at any point their SGPT value
rose to a Grade 4 (more than 10 times the upper limit of normal), they should not be
dosed with the Study Drug.

Exclusion Criteria:

- evidence of pre-existing fetal anomalies incompatible with life;

- known hypersensitivity to any benzodiazepine or to NVP;

- receipt of antiretroviral agent other than ZDV;

- receipt of non-allowed concomitant treatment;

- uncontrolled hypertension;

- concurrent participation in another clinical trial;

- women with a CD4 count <200/µL or history of oral candidiasis if they were not
receiving PCP prophylaxis.