AEGiS-13IAC: The one year safety and efficacy data of the HIVNET 012 trial.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

The one year safety and efficacy data of the HIVNET 012 trial.

Int Conf AIDS 2000 Jul 9-14; 13:16 (abstract no.. LbOr1)

Owor M, Deseyve M, Duefield C, Musisi M, Fleming T, Musoke P, Guay L, Mmiro F, Jackson B
MU-JHU Research Collaboration, Kampala, Uganda. Fax: +256 41-541044, E-mail: mujhu@afsat.com.

OBJECTIVE: Preliminary results of the Uganda HIVNET 012 trial of short-course nevirapine (NVP) vs short-course AZT to prevent perinatal HIV transmission were reported last year. Final HIV-transmission rates up to 14-16 weeks (data on additional 105 infants) are presented here, and safety and efficacy data on all 619 mother-infant pairs followed through age 12 months will be available and presented at the meeting.

METHODS: HIVNET 012 is a phase IIb trial that randomized 619 HIV-infected women and their infants to either: 200 mg of oral NVP to mother at onset of labor and 2 mg/kg oral NVP to infant within 72 h of birth or 600 mg of AZT to mother at onset of labor followed by 300 mg q3h until delivery and 4 mg/kg oral AZT BID to infant for 7 days. Infants were tested for HIV infection by HIV RNA (Roche Amplicor) at age 1-3 days, 6-8 weeks, 14-16 weeks, and 12 months, and by EIA/WB at 18 months. Kaplan-Meier analysis was used to assess HIV transmission rates. Serious adverse events (clinical and ≥ grade 3 laboratory toxicity) were assessed to 6 weeks postpartum for women and age 12 months for infants.

RESULTS: The final HIV transmission rates in 311 infants in the NVP and 308 infants in the AZT arms were: 8.1% vs 10.3% at birth, 11.8% vs 20.0% at 6-8 weeks (p=0.006), and 13.6% vs 22.1% at 14-16 weeks. Serious adverse events were not significantly different between NVP and AZT groups in either women or infants. The last enrolled infant will reach age 12 months in June 2000.

CONCLUSION: Study results continue to indicate that a single dose of NVP given to HIV+ women in labor and to the newborn within 72 h of birth was safe and significantly reduced mother-to-child HIV transmission rate compared with a short course AZT regimen in a breastfeeding population.

Keywords: AEGIS, Nevirapine, Zidovudine, HIV Infections, Safety, Breast Feeding, Delivery, Obstetric, Labor, Obstetric, Uganda, Infant, Human, Female, Pregnancy, Child, Infant, Newborn, transmission, surgery, AIDS
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