One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

Inclusion Criteria:

• Meet all pre-entry criteria;
• Consent to participate and to be followed for the duration of the study;

• Present the following laboratory values within 14 days prior to inclusion:

  • Hemoglobin > 8.0 mg/dl
  • Absolute neutrophil count > 1000 cells/mm3
  • Platelets > 100,000 cells/mm3
  • Serum creatinine < 1.5 mg/dl (women with a serum creatinine > 1.5 mg/dl must have a measured eight-hour urine creatinine clearance > 70 ml/min)
  • SGPT less than 10 times the upper limit of normal
  • Amylase less than 150/L IU (this upper limit may change slightly depending on the normal range at the hospital laboratory).

Exclusion Criteria:

• Evidence of pre-existing fetal anomalies incompatible with life;
• Known hypersensitivity to any benzodiazepine or to NVP;
• Receipt of antiretroviral agent other than ZDV;
• Receipt of non-allowed concomitant treatment or contraindication to ddI
• Concurrent participation in another clinical trial;
• Women with a CD4 count <200/µL or history of oral candidiasis if they are not receiving pneumocystis carinii pneumonia (PCP) prophylaxis
• Any other contra-indicated drugs during ZDV+ddI treatment for the mother as well as the child (Contra-indicated drugs such as gancyclovir, isoniazid, linezolid, ethambutol, rifabutin, cidofovir are not allowed during the ZDV ddI treatment after delivery in order to prevent pharmacological interactions or overlapping toxicities.)