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

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherche pour le Developpement
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Treatments: Lopinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

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.