Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV Seronegativity, Treatment Naive, Pregnancy, Perinatal Transmission, Vertical Transmission, Mother-To-Child Transmission, MTCT
Eligibility Criteria
Inclusion Criteria for Mothers: HIV infected Pregnant with a viable fetus Between 28 and 38 weeks of pregnancy CD4 count greater than 250 cells/mm3 within 30 days prior to study entry Able to receive oral ART during labor Willing to use acceptable forms of contraception while on study treatment Able to provide written informed consent Exclusion Criteria for Mothers: Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV Any ART other than ZDV during a previous pregnancy or the current pregnancy Certain medications Planning to receive additional ART during the first 8 weeks postpartum Planning to breastfeed Unlikely to comply with postpartum study requirements, in the opinion of the investigator Certain abnormal laboratory values within 30 days prior to study entry
Sites / Locations
- Siriraj Hospital Mahidol University CRS
- Bhumibol Adulyadej Hosp. CRS
- Prapokklao Hosp. CRS
- Chiang Mai University Pediatrics-Obstetrics CRS
- Chiangrai Prachanukroh Hospital CRS
- Chonburi Hosp. CRS
- Phayao Provincial Hosp. CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A: LPV/r x 7d
Arm B: no LPV/r
Arm C: LPV/r x 30d
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and BID for 7 days postpartum, ddI 250 mg orally daily (if body weight <60 kg) or 400 mg orally twice daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum , ddI 250 mg orally daily (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum , ddI 250 mg orally daily (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum,LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.