AEGiS-13IAC: Evaluation of safety of two simple regimens for prevention of mother to child transmission (MTCT) of HIV infection 'Nevirapine (NVP) vs lamivudine (3TC)+zidovudine (ZDV)' used in a randomized clinical trial (The SAINT Study).

13th International AIDS Conference

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

Evaluation of safety of two simple regimens for prevention of mother to child transmission (MTCT) of HIV infection 'Nevirapine (NVP) vs lamivudine (3TC)+zidovudine (ZDV)' used in a randomized clinical trial (The SAINT Study).

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. TuOrB356)

McIntyre J; J. McIntyre, Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, RSA, South Africa, Tel.: 27-11-938-3984, E-mail: rcurry@rdg.boehringer-ingelheim.com

BACKGROUND: The SAINT Study was conducted in South Africa to compare the efficacy of a short course of NVP with a short course of ZDV+3TC for prevention of MTCT of HIV. The assessment of safety is critical for MTCT prophylaxis.

METHODS: SAINT is an ongoing, randomized, open label, multicenter trial that will complete in May 2000. There are currently 1212 enrolled mothers. Women presenting in labour or very late during pregnancy were counseled and tested for HIV. HIV+ women who gave informed consent were randomized to NVP (200 mg dose during labour, and a second 200 mg dose 24 - 48 hours after delivery) or to ZDV (600 mg, then 300 mg q3h during labour and 300 mg BID subsequently) plus 3TC (150 mg BID) during labour, and then for 7 days. Respectively, the children were given a single 6 mg dose of NVP at 24 to 48 hours after birth, or ZDV (12 mg BID) plus 3TC (6 mg BID) for 7 days. Adverse events (AEs) were collected for up to 84 days. An analysis of the full patient data will be presented; interim analysis data is presented here.

RESULTS: Available for analysis were the first 528 mothers and 532 infants entered into the study. There were 7 (2.7%) all causality serious AEs (SAEs) reported for 264 NVP mothers and 4 (1.5%) for 264 ZDV+3TC mothers. There were 15 (5.7%) all causality SAEs for 265 NVP infants and 26 (9.7%) for 267 ZDV+3TC infants. There were no treatment related SAEs in mothers or infants in either group. Four deaths occurred in infants (ZDC+3TC: 3; NVP: 1). None were related to treatment. There were no maternal deaths.

CONCLUSION: The interim analysis of deaths and serious adverse events suggests that both treatment arms are similar and safe. The final analyses of AEs and deaths will be presented.

Keywords: AEGIS, Zidovudine, Nevirapine, Lamivudine, HIV Infections, Anti-HIV Agents, Randomized Controlled Trials, HIV, HIV Protease Inhibitors, Mothers, Safety, South Africa, Child, Human, Female, Infant, Pregnancy
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