Status:
TERMINATED
Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Pregnancy
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 t...
Detailed Description
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 rando...
Eligibility Criteria
Inclusion
- Pre-Entry Criteria
- Evidence of HIV infection (documented by two HIV antibody tests on two different dates)
- Intend to be followed at a study site for the duration of the study
- At least 18 years old
- Written informed consent.
- Inclusion Criteria:
- Women are eligible for the study if they
- met all pre-entry criteria
- Evidence of HIV infection, as documented by two serology tests obtained at two different dates;
- between 28 and 36 weeks gestational age;
- antiretroviral naïve except for exposure to ZDV prophylaxis PMTCT;
- CD4 count above 250 cells/mm3 (within 4 months prior to randomization)
- agreement not to breastfeed;
- consent to participate and to be followed for the duration of the study;
- and the following laboratory values within 14 days prior to randomization:
- hemoglobin \> 8.5 mg/dl;
- absolute neutrophil count \> 750 cells/mm3;
- platelets \> 50,000 cells/mm3;
- SGPT ≤ 5 times upper limit of normal;
- serum creatinine ≤ 1.5 times upper limit of normal (women with a serum creatinine \> 1.5 times upper limit of normal must have a measured eight-hour urine creatinine clearance \> 70 ml/min).
- Exclusion criteria:
- Evidence of pre-existing fetal anomalies incompatible with life;
- patients who meet the criteria of Classes III/IV of the WHO classification of HIV-associated clinical disease;
- known hypersensitivity to any benzodiazepine;
- active tuberculosis;
- concurrent participation to any other clinical trial;
- receipt of benzodiazepines or antiretroviral agent other than ZDV;
- uncontrolled hypertension;
- anticoagulant therapy or magnesium sulfate within 2 weeks of enrollment or the need for them during labor or at delivery.
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT00409591
Start Date
July 1 2008
End Date
June 1 2015
Last Update
January 28 2016
Active Locations (43)
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1
Health Promotion Hospital Regional Center I
Bangkok, Bangkok, Thailand, 10220
2
Nopparat Rajathanee Hospital
Kannayao, Bangkok, Thailand, 10230
3
Bhumibol Adulyadej Hospital
Saimai, Bangkok, Thailand
4
Chachoengsao Hospital
Muang, Changwat Chachoengsao, Thailand, 24000