Tags

Type your tag names separated by a space and hit enter

Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand.
N Engl J Med 2004; 351(3):217-28NEJM

Abstract

BACKGROUND

Although zidovudine prophylaxis decreases the rate of transmission of the human immunodeficiency virus (HIV) type 1 substantially, a large number of infants still become infected. We hypothesized that the administration, in addition to zidovudine, of a single dose of oral nevirapine to mothers during labor and to neonates would further reduce transmission of HIV.

METHODS

We conducted a randomized, double-blind trial of three treatment regimens in Thai women who were receiving zidovudine therapy during the third trimester of pregnancy. In one group, mothers and infants received a single dose of nevirapine (nevirapine-nevirapine regimen); in another, mothers and infants received nevirapine and placebo, respectively (nevirapine-placebo regimen); and in the last, mothers and infants received placebo (placebo-placebo regimen). The infants also received one week of zidovudine therapy and were formula-fed. The end point of the study was infection with HIV in the infants, established by virologic testing.

RESULTS

Between January 15, 2001, and February 28, 2003, a total of 1844 Thai women were enrolled. At the first interim analysis, the independent data monitoring committee stopped enrollment in the placebo-placebo group. Among women who delivered before the interim analysis, the as-randomized Kaplan-Meier estimates of the transmission rates were 1.1 percent (95 percent confidence interval, 0.3 to 2.2) in the nevirapine-nevirapine group and 6.3 percent (95 percent confidence interval, 3.8 to 8.9) in the placebo-placebo group (P<0.001). The final per-protocol transmission rate in the nevirapine-nevirapine group, 1.9 percent (95 percent confidence interval, 0.9 to 3.0), was not significantly inferior to the rate in the nevirapine-placebo group (2.8 percent; 95 percent confidence interval, 1.5 to 4.1). Nevirapine had an effect within subgroups defined by known risk factors such as viral load and CD4 count. No serious adverse effects were associated with nevirapine therapy.

CONCLUSIONS

A single dose of nevirapine to the mother, with or without a dose of nevirapine to the infant, added to oral zidovudine prophylaxis starting at 28 weeks' gestation, is highly effective in reducing mother-to-child transmission of HIV.

Authors+Show Affiliations

Epidémiologie Clinique, Santé Maternelle et Infantile et Sida, Institut de Recherche pour le Développement, Paris. marc@phpt.org.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 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

15247338

Citation

Lallemant, Marc, et al. "Single-dose Perinatal Nevirapine Plus Standard Zidovudine to Prevent Mother-to-child Transmission of HIV-1 in Thailand." The New England Journal of Medicine, vol. 351, no. 3, 2004, pp. 217-28.
Lallemant M, Jourdain G, Le Coeur S, et al. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004;351(3):217-28.
Lallemant, M., Jourdain, G., Le Coeur, S., Mary, J. Y., Ngo-Giang-Huong, N., Koetsawang, S., ... Thaineua, V. (2004). Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. The New England Journal of Medicine, 351(3), pp. 217-28.
Lallemant M, et al. Single-dose Perinatal Nevirapine Plus Standard Zidovudine to Prevent Mother-to-child Transmission of HIV-1 in Thailand. N Engl J Med. 2004 Jul 15;351(3):217-28. PubMed PMID: 15247338.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. AU - Lallemant,Marc, AU - Jourdain,Gonzague, AU - Le Coeur,Sophie, AU - Mary,Jean Yves, AU - Ngo-Giang-Huong,Nicole, AU - Koetsawang,Suporn, AU - Kanshana,Siripon, AU - McIntosh,Kenneth, AU - Thaineua,Vallop, AU - ,, Y1 - 2004/07/09/ PY - 2004/7/13/pubmed PY - 2004/7/22/medline PY - 2004/7/13/entrez SP - 217 EP - 28 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 351 IS - 3 N2 - BACKGROUND: Although zidovudine prophylaxis decreases the rate of transmission of the human immunodeficiency virus (HIV) type 1 substantially, a large number of infants still become infected. We hypothesized that the administration, in addition to zidovudine, of a single dose of oral nevirapine to mothers during labor and to neonates would further reduce transmission of HIV. METHODS: We conducted a randomized, double-blind trial of three treatment regimens in Thai women who were receiving zidovudine therapy during the third trimester of pregnancy. In one group, mothers and infants received a single dose of nevirapine (nevirapine-nevirapine regimen); in another, mothers and infants received nevirapine and placebo, respectively (nevirapine-placebo regimen); and in the last, mothers and infants received placebo (placebo-placebo regimen). The infants also received one week of zidovudine therapy and were formula-fed. The end point of the study was infection with HIV in the infants, established by virologic testing. RESULTS: Between January 15, 2001, and February 28, 2003, a total of 1844 Thai women were enrolled. At the first interim analysis, the independent data monitoring committee stopped enrollment in the placebo-placebo group. Among women who delivered before the interim analysis, the as-randomized Kaplan-Meier estimates of the transmission rates were 1.1 percent (95 percent confidence interval, 0.3 to 2.2) in the nevirapine-nevirapine group and 6.3 percent (95 percent confidence interval, 3.8 to 8.9) in the placebo-placebo group (P<0.001). The final per-protocol transmission rate in the nevirapine-nevirapine group, 1.9 percent (95 percent confidence interval, 0.9 to 3.0), was not significantly inferior to the rate in the nevirapine-placebo group (2.8 percent; 95 percent confidence interval, 1.5 to 4.1). Nevirapine had an effect within subgroups defined by known risk factors such as viral load and CD4 count. No serious adverse effects were associated with nevirapine therapy. CONCLUSIONS: A single dose of nevirapine to the mother, with or without a dose of nevirapine to the infant, added to oral zidovudine prophylaxis starting at 28 weeks' gestation, is highly effective in reducing mother-to-child transmission of HIV. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15247338/Single_dose_perinatal_nevirapine_plus_standard_zidovudine_to_prevent_mother_to_child_transmission_of_HIV_1_in_Thailand_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa033500?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -