Status:
COMPLETED
Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
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 the study was to test the equivalence of a short zidovudine (ZDV) regimen as compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child transmission of HIV...
Detailed Description
Multicenter, randomized, four arms, double-blind, controlled study. Consenting pregnant women were tested for HIV from the beginning of pregnancy until 26 of gestational age (GA). If HIV-positive and ...
Eligibility Criteria
Inclusion
- Pre-inclusion
- Women are eligible for Pre-Entry if they:
- have evidence of HIV infection (confirmed on a second sample);
- present themselves for prenatal care before 26 weeks GA, based on last menstrual period and/or sonogram results;
- intend to stay in the province for at least 18 months after delivery;
- can provide informed consent;
- have given written informed consent to participate in the study;
- intend to carry the pregnancy to term.
- all pre-entry criteria;
- date of enrollment: 28 weeks GA, based on last menstrual period and/or sonogram results;
- the following laboratory values within 21 days prior to randomization:
- hemoglobin \> 8.0 g/dL;
- absolute neutrophil count \> 750 cells/mm3;
- SGPT \< 5 x upper limit of normal;
- 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.);
- agreement not to breastfeed.
Exclusion
- AIDS according to the Thai Communicable Diseases Control (CDC) classification;
- pre-existing maternal/fetal condition that contraindicates the use of ZDV
- oligohydramnios, unexplained polyhydramnios, fetal hydrops or ascites or other evidence of pre-existing in-utero anemia;
- clinically significant history of intolerance to ZDV treatment resulting in discontinuation of therapy for more than 4 weeks;
- receipt of ZDV during the current pregnancy for any indication, or women who need ZDV for their own health (women are then followed separately);
- receipt of other antiretroviral agents, passive immunotherapy, anti-HIV vaccines, cytolytic agents (usually referred as chemotherapy), radiation therapy, or corticosteroids during this pregnancy except steroids less than 7 (see Zidovudine Investigator's Brochure);
- simultaneous participation in another clinical trial.
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
End Date :
August 1 2000
Estimated Enrollment :
1554 Patients enrolled
Trial Details
Trial ID
NCT00386230
Start Date
June 1 1997
End Date
August 1 2000
Last Update
May 2 2008
Active Locations (1)
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1
Phpt - Ird 174
Chiang Mai, Chiang Mai, Thailand, 50200