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Randomized placebo-controlled trial of short-course oral ZDV to reduce perinatal HIV transmission, Thailand.




 

Int Conf AIDS. 1998;12:624 (abstract no. 30/33163). Unique Identifier :

BACKGROUND: Many developing countries with high burdens of perinatal HIV infection have not implemented the ACTG 076 regimen because of logistical and cost barriers. If proven safe and effective, a short-course oral zidovudine (ZDV) regimen administered to HIV-infected women late in pregnancy could become a widely implemented minimum alternative regimen for reducing perinatal HIV transmission. METHODS: A randomized, double-blind, placebo-controlled trial is being conducted in Bangkok at Thailand's two largest maternity hospitals. The study regimen is oral ZDV 300 mg taken twice daily by HIV+ women beginning at 36 weeks gestation and every 3 hours during labor. No ZDV is given to the newborn. Mothers do not breast-feed, consistent with national guidelines. The target sample size is 392 women (196 in each arm), and has the power (alpha = .05, beta = .2) to detect a 50% decrease in transmission from a presumed background rate of 24%. Infants are tested by DNA PCR at birth, 2 and 6 months. Efficacy is based on estimated transmission rates at 6 months by Kaplan-Meier analysis of time to a positive PCR test. The study is monitored by an independent DSMB. RESULTS: Full study enrollment was completed from May 1996 through December 1997. Through 1997, there were 382 births (2 sets of twins); 313 children have been followed through 2 months and 222 children through 6 months. The median age of women at enrollment is 24 yrs (range 17-39) and the median CD4+ cell count is 412 cells/microL (range 6-1317). The median number of days on study drug before labor is 24 (range 3-58) and the median number of labor doses is 3. Weekly reviews of study drug, pill counts and qualitative interviews indicate a very high level of adherence (> 95%) and tolerance. No woman has had to stop study drug. Thus far, more than 95% of expected study visits have been completed and < 5% of children have been lost to follow-up. CONCLUSIONS: Full study enrollment was completed in 1997. The study regimen, including the oral labor doses, has been well tolerated and adherence and follow-up have been > 95%, suggesting that this short-course regimen would be feasible to implement in Thailand, and perhaps in other developing countries. There were two interim efficacy reviews by the DSMB. We expect to announce nearly final results by March 1998.

MEETING ABSTRACTS CLINICAL TRIAL RANDOMIZED CONTROLLED TRIAL Administration, Oral Adolescence Adult Anti-HIV Agents/*THERAPEUTIC USE CD4 Lymphocyte Count Disease Transmission, Vertical/*PREVENTION & CONTROL Double-Blind Method Drug Administration Schedule Female Hospitals, Maternity Human HIV Infections/IMMUNOLOGY/*PREVENTION & CONTROL/TRANSMISSION Infant, Newborn Neonatal Screening Pregnancy Pregnancy Complications, Infectious/IMMUNOLOGY/*PREVENTION & CONTROL Proportional Hazards Models Questionnaires Thailand Time Factors Zidovudine/*THERAPEUTIC USE



 




Information in this article was accurate in December 30, 1998. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.