Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana.
BACKGROUND
Single-dose nevirapine given to women and infants reduces mother-to-child HIV transmission, but nevirapine resistance develops in a large percentage of women.


OBJECTIVE
To determine whether the maternal nevirapine dose could be eliminated in the setting of zidovudine prophylaxis.


METHODS
A 2 x 2 factorial, randomized, clinical trial, with a double-blinded peripartum factor designed to assess the equivalence of maternal single-dose nevirapine versus placebo with respect to HIV transmission. A total of 709 HIV-infected pregnant women were randomized from four district hospitals in Botswana, resulting in 694 live first-born infants. HAART was available for women with AIDS.


METHODS
All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.


METHODS
The primary endpoint was infant HIV infection by the 1-month visit.


RESULTS
Of the 694 infants in this equivalence study, 15 (4.3%) of 345 in the maternal nevirapine arm were HIV infected by 1 month, versus 13 (3.7%) of 349 in the maternal placebo arm (95% confidence interval for difference, -2.4% to 3.8%), meeting pre-determined equivalence criteria. Nevirapine resistance at 1 month postpartum was detected in 45% of a random sample of women who received nevirapine.


CONCLUSIONS
In the setting of maternal zidovudine and infant zidovudine plus single-dose nevirapine, infant HIV infection rates were similar whether women received single-dose nevirapine or placebo. This strategy avoids the potential for maternal nevirapine resistance.
Shapiro
Roger L
RL
Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Thior
Ibou
I
Gilbert
Peter B
PB
Lockman
Shahin
S
Wester
Carolyn
C
Smeaton
Laura M
LM
Stevens
Lisa
L
Heymann
S Jody
SJ
Ndung'u
Thumbi
T
Gaseitsiwe
Simani
S
Novitsky
Vladimir
V
Makhema
Joseph
J
Lagakos
Stephen
S
Essex
Max
M
D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active; D001902:Botswana; D004334:Drug Administration Schedule; D024882:Drug Resistance, Viral; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D019259:Lamivudine / Q000008:administration & dosage / Q000627:therapeutic use; D016015:Logistic Models; D019829:Nevirapine / Q000008:administration & dosage*; D049590:Postpartum Period; D016896:Treatment Outcome; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use
D044966:Anti-Retroviral Agents; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine