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Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial.
JAMA 2004; 292(2):202-9JAMA

Abstract

CONTEXT

Antenatal counseling and human immunodeficiency virus (HIV) testing are not universal in Africa; thus, women often present in labor with unknown HIV status without receiving the HIVNET 012 nevirapine (NVP) regimen (a single oral dose of NVP to the mother at the start of labor and to the infant within 72 hours of birth).

OBJECTIVE

To determine risk of mother-to-child transmission of HIV when either standard use of NVP alone or in combination with zidovudine (ZDV) was administered to infants of women tested at delivery.

DESIGN, SETTING, AND PARTICIPANTS

A randomized, open-label, phase 3 trial conducted between April 1, 2000, and March 15, 2003, at 6 clinics in Blantyre, Malawi, Africa. The trial included all infants born to 894 women who were HIV positive, received NVP intrapartum, and were previously antiretroviral treatment-naive. Infants were randomly assigned to NVP (n = 448) and NVP plus ZDV (n = 446). Infants were enrolled at birth, observed at 6 to 8 weeks, and followed up through 3 to 18 months. The HIV status of 90% of all infants was established at 6 to 8 weeks.

INTERVENTION

Mothers received a 200-mg single oral dose of NVP intrapartum and infants received either 2-mg/kg oral dose of NVP or NVP (same dose) plus 4 mg/kg of ZDV twice per day for a week.

MAIN OUTCOME MEASURES

HIV infection of infant at birth and 6 to 8 weeks, and adverse events.

RESULTS

The mother-to-child transmission of HIV at birth was 8.1% (36/445) in infants administered NVP only and 10.1% (45/444) in those administered NVP plus ZDV (P =.30). A life table estimate of transmission at 6 to 8 weeks was 14.1% (95% confidence interval [CI], 10.7%-17.4%) in infants who received NVP and 16.3% (95% CI, 12.7%-19.8%) in those who received NVP plus ZDV (P =.36). For infants not infected at birth and retested at 6 to 8 weeks, transmission was 6.5% (23/353) in those who received NVP only and 6.9% (25/363) in those who received NVP plus ZDV (P =.88). Almost all infants (99%-100%) were breastfed at 1 week and 6 to 8 weeks. Grades 3 and 4 adverse events were comparable; 4.9% (22/448) and 5.4% (24/446) in infants receiving NVP only and NVP plus ZDV, respectively (P =.76).

CONCLUSIONS

The frequency of mother-to-child HIV transmission at 6 to 8 weeks in our 2 study groups was comparable with that observed for other perinatal HIV intervention studies among breastfeeding women in Africa. The safety of the regimen containing neonatal ZDV was similar to that of a standard NVP regimen.

Authors+Show Affiliations

Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md 21205, USA. ttaha@jhsph.eduNo 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
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15249569

Citation

Taha, Taha E., et al. "Nevirapine and Zidovudine at Birth to Reduce Perinatal Transmission of HIV in an African Setting: a Randomized Controlled Trial." JAMA, vol. 292, no. 2, 2004, pp. 202-9.
Taha TE, Kumwenda NI, Hoover DR, et al. Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial. JAMA. 2004;292(2):202-9.
Taha, T. E., Kumwenda, N. I., Hoover, D. R., Fiscus, S. A., Kafulafula, G., Nkhoma, C., ... Broadhead, R. L. (2004). Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial. JAMA, 292(2), pp. 202-9.
Taha TE, et al. Nevirapine and Zidovudine at Birth to Reduce Perinatal Transmission of HIV in an African Setting: a Randomized Controlled Trial. JAMA. 2004 Jul 14;292(2):202-9. PubMed PMID: 15249569.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial. AU - Taha,Taha E, AU - Kumwenda,Newton I, AU - Hoover,Donald R, AU - Fiscus,Susan A, AU - Kafulafula,George, AU - Nkhoma,Chiwawa, AU - Nour,Samah, AU - Chen,Shu, AU - Liomba,George, AU - Miotti,Paolo G, AU - Broadhead,Robin L, PY - 2004/7/14/pubmed PY - 2004/7/17/medline PY - 2004/7/14/entrez SP - 202 EP - 9 JF - JAMA JO - JAMA VL - 292 IS - 2 N2 - CONTEXT: Antenatal counseling and human immunodeficiency virus (HIV) testing are not universal in Africa; thus, women often present in labor with unknown HIV status without receiving the HIVNET 012 nevirapine (NVP) regimen (a single oral dose of NVP to the mother at the start of labor and to the infant within 72 hours of birth). OBJECTIVE: To determine risk of mother-to-child transmission of HIV when either standard use of NVP alone or in combination with zidovudine (ZDV) was administered to infants of women tested at delivery. DESIGN, SETTING, AND PARTICIPANTS: A randomized, open-label, phase 3 trial conducted between April 1, 2000, and March 15, 2003, at 6 clinics in Blantyre, Malawi, Africa. The trial included all infants born to 894 women who were HIV positive, received NVP intrapartum, and were previously antiretroviral treatment-naive. Infants were randomly assigned to NVP (n = 448) and NVP plus ZDV (n = 446). Infants were enrolled at birth, observed at 6 to 8 weeks, and followed up through 3 to 18 months. The HIV status of 90% of all infants was established at 6 to 8 weeks. INTERVENTION: Mothers received a 200-mg single oral dose of NVP intrapartum and infants received either 2-mg/kg oral dose of NVP or NVP (same dose) plus 4 mg/kg of ZDV twice per day for a week. MAIN OUTCOME MEASURES: HIV infection of infant at birth and 6 to 8 weeks, and adverse events. RESULTS: The mother-to-child transmission of HIV at birth was 8.1% (36/445) in infants administered NVP only and 10.1% (45/444) in those administered NVP plus ZDV (P =.30). A life table estimate of transmission at 6 to 8 weeks was 14.1% (95% confidence interval [CI], 10.7%-17.4%) in infants who received NVP and 16.3% (95% CI, 12.7%-19.8%) in those who received NVP plus ZDV (P =.36). For infants not infected at birth and retested at 6 to 8 weeks, transmission was 6.5% (23/353) in those who received NVP only and 6.9% (25/363) in those who received NVP plus ZDV (P =.88). Almost all infants (99%-100%) were breastfed at 1 week and 6 to 8 weeks. Grades 3 and 4 adverse events were comparable; 4.9% (22/448) and 5.4% (24/446) in infants receiving NVP only and NVP plus ZDV, respectively (P =.76). CONCLUSIONS: The frequency of mother-to-child HIV transmission at 6 to 8 weeks in our 2 study groups was comparable with that observed for other perinatal HIV intervention studies among breastfeeding women in Africa. The safety of the regimen containing neonatal ZDV was similar to that of a standard NVP regimen. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/15249569/Nevirapine_and_zidovudine_at_birth_to_reduce_perinatal_transmission_of_HIV_in_an_African_setting:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.292.2.202 DB - PRIME DP - Unbound Medicine ER -