Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1

• Status: Completed
• Trial end date: 2000-08-01
• Target enrollment: 0
• Participant gender: Female

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: and to assess and compare the safety and tolerance of the long and shortened ZDV regimens.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherche pour le Developpement
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Treatments: Zidovudine

Criteria

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.

Inclusion Criteria:

• 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 Criteria:

• 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.