Status:
COMPLETED
Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 ...
Detailed Description
Multicenter, randomized, three arms, double-blind, controlled study. Study population was HIV-infected pregnant women who were on ZDV prophylaxis for more than two weeks and gave informed consent. If ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
1792 Patients enrolled
Trial Details
Trial ID
NCT00398684
Start Date
January 1 2001
End Date
June 1 2004
Last Update
May 7 2008
Active Locations (1)
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1
Phpt - Ird 174
Chiang Mai, Chiang Mai, Thailand, 50200