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Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial.
Lancet. 1999 Sep 04; 354(9181):795-802.Lct

Abstract

BACKGROUND

The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life.

METHODS

From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis.

FINDINGS

Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p=0.354); 21.3% and 11.9% by age 6-8 weeks (p=0.0027); and 25.1% and 13.1% by age 14-16 weeks (p=0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20-64) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups.

INTERPRETATION

Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries.

Authors+Show Affiliations

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

10485720

Citation

Guay, L A., et al. "Intrapartum and Neonatal Single-dose Nevirapine Compared With Zidovudine for Prevention of Mother-to-child Transmission of HIV-1 in Kampala, Uganda: HIVNET 012 Randomised Trial." Lancet (London, England), vol. 354, no. 9181, 1999, pp. 795-802.
Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999;354(9181):795-802.
Guay, L. A., Musoke, P., Fleming, T., Bagenda, D., Allen, M., Nakabiito, C., Sherman, J., Bakaki, P., Ducar, C., Deseyve, M., Emel, L., Mirochnick, M., Fowler, M. G., Mofenson, L., Miotti, P., Dransfield, K., Bray, D., Mmiro, F., & Jackson, J. B. (1999). Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet (London, England), 354(9181), 795-802.
Guay LA, et al. Intrapartum and Neonatal Single-dose Nevirapine Compared With Zidovudine for Prevention of Mother-to-child Transmission of HIV-1 in Kampala, Uganda: HIVNET 012 Randomised Trial. Lancet. 1999 Sep 4;354(9181):795-802. PubMed PMID: 10485720.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. AU - Guay,L A, AU - Musoke,P, AU - Fleming,T, AU - Bagenda,D, AU - Allen,M, AU - Nakabiito,C, AU - Sherman,J, AU - Bakaki,P, AU - Ducar,C, AU - Deseyve,M, AU - Emel,L, AU - Mirochnick,M, AU - Fowler,M G, AU - Mofenson,L, AU - Miotti,P, AU - Dransfield,K, AU - Bray,D, AU - Mmiro,F, AU - Jackson,J B, PY - 1999/9/15/pubmed PY - 2000/2/19/medline PY - 1999/9/15/entrez KW - Africa KW - Africa South Of The Sahara KW - Age Factors KW - Clinical Research KW - Comparative Studies KW - Demographic Factors KW - Developing Countries KW - Diseases KW - Drugs--therapeutic use KW - Eastern Africa KW - English Speaking Africa KW - Hiv Infections KW - Infant KW - Population KW - Population Characteristics KW - Pregnant Women KW - Research Methodology KW - Research Report KW - Studies KW - Treatment KW - Uganda KW - Vertical Transmission KW - Viral Diseases KW - Youth SP - 795 EP - 802 JF - Lancet (London, England) JO - Lancet VL - 354 IS - 9181 N2 - BACKGROUND: The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life. METHODS: From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis. FINDINGS: Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p=0.354); 21.3% and 11.9% by age 6-8 weeks (p=0.0027); and 25.1% and 13.1% by age 14-16 weeks (p=0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20-64) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups. INTERPRETATION: Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/10485720/Intrapartum_and_neonatal_single_dose_nevirapine_compared_with_zidovudine_for_prevention_of_mother_to_child_transmission_of_HIV_1_in_Kampala_Uganda:_HIVNET_012_randomised_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(99)80008-7 DB - PRIME DP - Unbound Medicine ER -