|
|
|
|
|
|
Sponsors and Collaborators: |
Institut de Recherche pour le Developpement Harvard School of Public Health National Institute of Child Health and Human Development (NICHD) |
Information provided by: | Institut de Recherche pour le Developpement |
ClinicalTrials.gov Identifier: | NCT00409591 |
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.
Condition | Intervention | Phase |
HIV Infections Pregnancy |
Drug: Maternal and infant nevirapine Drug: Maternal placebo and infant nevirapine Drug: Maternal lopinavir+ritonavir |
Phase III |
MedlinePlus related topics: | AIDS AIDS and Pregnancy |
Drug Information available for: | Zidovudine Ritonavir Nevirapine Lopinavir |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 2097 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2014 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
NVP-NVP:
|
Drug: Maternal and infant nevirapine
|
2: Experimental
PL-NVP:
|
Drug: Maternal placebo and infant nevirapine
Comparison between Arms 1 and 2 is double-blinded. |
3: Experimental
LPV/r: - In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines. |
Drug: Maternal lopinavir+ritonavir
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
|
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:
Arm 2: PL-NVP:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Pre-Entry Criteria
Inclusion Criteria:
Women are eligible for the study if they
Exclusion criteria:
If any of these conditions occurs after randomization, the women will be excluded from study drug dosing. Women with CD4 count lower than 250 cells/mm3 will be excluded from the study and offered HAART in the context of the national program.
Contact: Marc Lallement, MD | +6653814633-8 ext 0 | marc@phpt.org |
Contact: Gonzague Jourdain, MD, PhD | +6653814633-8 ext 0 | gonzague@phpt.org |
Show 29 Study Locations |
Institut de Recherche pour le Developpement |
Harvard School of Public Health |
National Institute of Child Health and Human Development (NICHD) |
Principal Investigator: | Marc Lallemant, MD | Institut de Recherche pour le Developpment |
Program for HIV Prevention and Treatment (Thailand) 
  |
Responsible Party: | Harvard School of Public Health & Institut de Recherche pour le Developpement ( Marc Lallemant ) |
Study ID Numbers: | PHPT-5; R01 HD052461; HD056953 |
First Received: | December 8, 2006 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00409591 |
Health Authority: | Thailand: Ministry of Public Health |
|
|
|
|
|
|