Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand

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.