HIV Infections Clinical Trial
Official title:
Maternal and Infant Peripartum Nevirapine, Versus Infant Only Peripartum Nevirapine, or Maternal Lopinavir/Ritonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand.
The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention of mother-to-child transmission of HIV-1.
Multicenter, placebo-controlled, double blind, clinical trial where non immunocompromised
women receiving the ZDV prophylaxis regimen from 28 weeks gestation, as recommended in
Thailand, will be randomized to one of two arms:
Arm 1: NVP-NVP:
- In women, one NVP 200 mg tablet at onset of labor+;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus
a second dose between 48 and 72 hours+++
Arm 2: PL-NVP:
- In women, one placebo tablet at onset of labor++;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus
a second dose between 48 and 72 hours+++
Arm 3: LPV/r:
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
- women in Arm 1 will also receive 7-day ZDV 300mg bid plus 3TC 150mg bid from
delivery. ++women in Arm 2 will also receive 7-day (ZDV+3TC) Placebo from
delivery. +++If the new born weight less than 2500 g, nevirapine will be
administered 2 mg./1 kg (As per Thai Guideline).
All infants will receive ZDV for at least one week. Follow-up of women and infants is
carried out on an outpatient basis except for delivery and the first three days after
delivery. Mothers and infants are followed-up for 24 months after delivery.
Note: The study was stopped and data unblinded upon DSMB recommendations in September 2010
because of changes in Thai PMTCT guidelines recommending use of HAART in all HIV infected
pregnant women regardless of their CD4 count. At the time of unblinding 435 pregnant women
had been enrolled and follow-up of these women and their children is continuing.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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