July, 15, 1999
The two drugs compared in this study were nevirapine and zidovudine (also known as ZDV or AZT). Nevirapine is a non-nucleoside reverse transcriptase inhibitor that has many attractive features. In addition to being a safe and potent antiviral drug, nevirapine remains active in the body for a long time and is rapidly absorbed and transferred to the fetus in the womb. For these reasons, researchers hypothesized that a single dose of nevirapine given to the mother and to the infant might provide enough protection to the baby to prevent HIV transmission during labor.
Women were randomly assigned to receive either:
Note: HIVNET 012 was originally designed as a double-blind, placebo-controlled study in 1500 women and their newborns in Uganda. After the announcement of the results of the CDC-sponsored Thai zidovudine trial in February 1998, the placebo arm in HIVNET 012 was discontinued. The study was redesigned to compare nevirapine to zidovudine.
At 6-8 weeks of age, 11.9 percent of infants in the nevirapine group were HIV-infected compared to 21.3 percent of infants in the zidovudine group. At 14-16 weeks of age, 13.1 percent of infants in the nevirapine group were infected compared with 25.1 percent of infants in the zidovudine group.
This study did not compare the effectiveness of nevirapine or zidovudine to placebo reducing mother to infant transmission. However, if the short-course zidovudine reg-imen is more effective than placebo, the benefit of the nevirapine regimen over placebo would be even greater than its benefit over zidovudine.
HIVNET-supported researchers from Makerere University in Kampala, Uganda, and Johns Hopkins University in Baltimore conducted the study. Glaxo-Wellcome and Boehringer-Ingelheim Pharmaceuticals provided the drugs used in the study.
Mothers and children will continue to be followed until 18 months of age to determine the long-term impact of the treatment in preventing maternal-infant transmission of HIV.
The long-course zidovudine regimen used in AIDS Clinical Trial Group protocol 076 (ACTG 076), now the standard of care for HIV-infected pregnant women in the United States, is unaffordable in many developing countries, where annual per capita spending on health is often less than $10. The cost of the drugs alone for the 076 regimen is 80 times that amount. Successful implementation of the 076 regimen also requires that women receive prenatal care early in their pregnancy. Recently studied shorter courses of zidovudine plus the drug lamivudine (3TC) have lowered the cost of treatment, but all are still substantially more expensive than the cost of the nevirapine regimen used in this study.
A recent study in Ivory Coast and Burkina Faso, sponsored by France's ANRS using zidovudine before, during labor, and after birth, showed a 38 percent reduction of transmission at six months of age.
Results in the zidovudine arm in the 012 study are consistent with a modest reduction in transmission observed in some other studies. When transmission risk in Ugandan infants on the placebo arm in the PETRA trial or in breastfed Kenyan infants in the Nuadi-Kreiss trial is compared to the zidovudine arm in this study, the transmission rates are comparable.
In addition, data from the 49 infants randomized to the placebo arm before the study was redesigned suggest that there is a small benefit in the zidovudine arm compared to placebo.
Another practical advantage is that nevirapine can be stored in hot climates.
Prepared by: Office of Communications and Public Liaison National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, MD 20892-2520
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Last Updated July 14, 1999