Table 10Evidence Table: Randomized Controlled Trials of Short Courses of Combination Antiretroviral Therapy for Reduction of Mother-to-Child Transmission of HIV Infection

Study, yearLocationAimsStudy durationEligibility criteria, momEligibility criteria, babyExclusion criteria, momExclusion criteria, babyScreened/eligible/enrolledWithdrawals or lost of follow-up/% analyzedPopulation characteristicsTreatmentCesarean rateBreastfeeding rateTransmission rateOther risk factors associated with mother-to-child transmissionAdverse eventsInternal validity rating
HIVNET 012AfricaTo determine the efficacy of intrapartum and newborn treatment with nevirapine vs. ZDV in reduction of mother-to-child transmission of HIVNov. 3, 1997-April 30, 1999HIV positive, at least 18 years of age; at more than 32 weeks gestation at enrollment, and lived within 15 km of Mulago Hospital, normal kidney and liver function, normal hematological parametersMom in study, firstbornCurrent antiretroviral or HIV-1 immunotherapy; uncontrolled hypertension; chronic alcohol or illicit drug use; and receipt of benzodiazepines, anticoagulant therapy, or magnesium sulfate within 2 weeks of enrollment or would require them during labor or at deliveryHIV status not known13,839 screened, 2,144 eligible, 645 enrolled10 lost to follow-up, 7 with insufficient dataMedian age A. 24, B. 25A. Nevirapine orally as a single dose intrapartum and to newbornA. 11.5%A. 99.3%A. 11.8%Maternal HIV RNA level at entry increased rate, for each unit increase of log OR 1.81 (1.36–2.40); maternal CD4 count at entry increased rate, for each decrease of 100 cells/microliter OR 1.19 (1.09–1.31)No significant difference in rates of serious adverse events in mothers or infants between treatment groupsGOOD
Jackson et al, 2003160 Randomized:Analyzed:Median CD4 count (cells/microL):B. ZDV orally intrapartum and to newborn for 7 daysB. 13.9%B. 98.7%B. 20.0%Open label
Guay et al, 1999162 A. 313A. 308A. 459At birthAt 6 weeks
B. 313B. 302B. 426
C. 19 (discontinued arm)
NVAZAfricaTo determine whether post-exposure prophylaxis of nevirapine plus ZDV given to newborns reduced mother-to-child transmission of HIV compared to nevirapine aloneApril 2000-Jan. 2002Unknown HIV status when presenting in advanced labor, HIV positive at deliveryMother HIV positive, singleton, not pretermReceipt of predelivery antiretroviral treatmentLow Apgar score, condition requiring admission to neonatal intensive care unit, HIV positive at birth12,355 screened, 1,119 randomized119 infants excluded, 135 lost to follow-upMedian maternal age 25A. Single dose of nevirapine to newbornA. 0.7%A. 99.8%A. 20.9%Maternal viral load (per log 10 increase) increased rate OR 3.18 (2.08–4.63)No significant differences in adverse events between groupsGOOD
Taha et al, 2003159 Analyzed:Median CD4 count not reportedB. Single dose of nevirapine and of ZDV to newborn, ZDV for 1 weekB. 0.5%B. 99.6%B. 15.3%Open label
A. 444At 1 weekAt 6–8 weeks of age
B. 421p=0.03
SAINTAfricaTo determine the efficacy and safety of 2 antiretroviral therapy regimens for prevention of mother-to-child transmission of HIVMay 1999-Feb. 2000HIV positive, agree to randomization, >16, >38 weeks gestation at presentation in latent or active laborMom in studyElective cesarean section planned, life-threatening obstetrical complicationsHIV status not known1,373 screened390 lost to follow-upMedian age at entry 25, median CD4 count (cells/microL):A: Nevirapine in labor and postpartum for 48 hoursA. 27.8%A. 46.2%A: 5.7%Breastfeeding at 4–8 weeks increased rate OR 7.23 (2.06–25.34)No significant difference in rates of serious adverse events in mothers or infants between treatment groupsGOOD
Moodley et al, 2003158 A: 662 randomizedAnalyzed:A. 404.5B: ZDV/3TC in labor and 1 week postpartumB. 31.4%B. 47.7%B: 3.6%Baseline maternal HIV RNA level >50,000 copes/mL increased rate OR 2.9 (1.8–4.8)Open label
B: 657 randomizedA: 477B. 384.5Ever breastfedAt 8 weeks postpartumMaternal antiretroviral dose <2 hours prior to delivery increased rate OR 3.1 (1.4–7.1)
B. 467Emergency cesarean section increased rate OR 2.5 (1.1–5.6)
PETRAAfricaTo assess the efficacy of short-course regimens with ZDV and 3TCJune 1996-Feb. 1998HIV positive, agree to randomization, older than 18 years of age or legal age of consent, ability to give informed consent, less than 36 weeks gestation at enrollment, absence of severe fetal anomalies, absence of life-threatening disease, normal hemoglobin, 18 month follow-up possibleMom in studyDiedHIV status not known4,640 screened;A. 84 lost to follow-up, 268 analyzedMedian age 26, median CD4 count (cells/microL):A: ZDV + 3TC at 36 weeks, intrapartum and 7 days postpartumA. 33%,A. 74%A: 5.7% RR 0.37 (0.21–0.65)Cesarean section lowered risk of transmission OR 0.60 (0.41–0.87)No significant difference in rates of serious adverse clinical or laboratory events in mothers or infants or in congenital anomalies between treatment groupsGOOD
PETRA Study Team, 2002155 A. 366 randomizedB. 120 lost to follow-up, 251 analyzedA. 445B: ZDV and 3TC intrapartum and 7 days postpartumB. 35%B. 73%B: 8.9% RR 0.58 (0.36–0.94)Higher maternal CD4 count lowered risk of transmission OR 0.89 (0.83–0.95) per 100 CD4 cells increment
B. 371 randomizedC. 113 lost to follow-up, 255 analyzedB. 475C: ZDV and 3TC intrapartum onlyC. 32%C. 76%C: 14.2% RR 0.93 (0.62–1.40)Breastfeeding at 18 months associated with higher risk of transmission OR 2.18 (1.50–3.17)
C. 368 randomizedD. 99 lost to follow-up, 253 analyzedC. 440D: placeboD. 33%D. 74%D: 15.3% RR 1.0
D. 352 randomizedD. 435At birthAt 6 weeks postpartum
NVAZAfricaTo determine the risk of mother-to-child transmission of HIV with nevirapine alone or with ZDV administered intrapartum and to infants after deliveryApril 2000-March 2003Presented to labor ward more than 4 hours prior to delivery, able to provide informed consent, HIV positiveMom in studyConfirmatory ELISA test negativeAnemic, pre-term, admission to the neonatal intensive care unit, HIV status not known9,469 women screened, 894 randomized5 excluded, 286 lost to follow-upMedian age 25, median CD count not reportedA. Single oral dose of nevirapine intrapartum and single oral dose of nevirapine to infantA. 3.5%A. 99.2%A. 6.5%Maternal viral load increased rate per log 10 increase OR 2.66 (1.95–3.63)No significant difference in rates of serious adverse clinical or laboratory events in mothers or infants between treatment groupsGOOD
Taha et al, 2004161 A. 389B. Single oral dose of nevirapine intrapartum and single oral dose of nevirapine plus ZDV for 1 week to infantB. 1.1%B. 100%B. 6.9%Open label
B. 408At 1 weekAt 6–8 weeks

ELISA, enzyme-linked immunoabsorbent assay; 3TC, lamivudine; ZDV, zidovudine.

From: 3, Results

Cover of Screening for Human Immunodeficiency Virus in Pregnant Women
Screening for Human Immunodeficiency Virus in Pregnant Women [Internet].
Evidence Syntheses, No. 39.
Chou R, Smits AK, Huffman LH, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.