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.