Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who previously received NVP for the prevention of mother to child transmission.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nevirapine; Zidovudine

Criteria

INCLUSION CRITERIA

• HIV-1-infected non-pregnant women who received a nevirapine regimen, for the prevention of mother to child transmission, at least 12 months previously.

• Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and ensure double barrier methods of contraception, which by definition will in all cases include the use of condoms, throughout the study period.

• CD4 cell count < 350 cells/mm3 and viral load HIV-1 RNA > 20,000 c/mL or any symptomatic individual (WHO stage 3) or the presence of any AIDS defining criteria.

• Documented HIV-1 positive status by a licensed HIV-1 ELISA test.

EXCLUSION CRITERIA

• Women who are pregnant or breastfeeding.

• Women with prior exposure to antiretroviral therapy, other than a nevirapine regimen for the prevention of mother to child transmission at least 12 months previously.

• Subjects who in the investigator's opinion are unlikely to complete the 48 week study period or unlikely to comply with the dosing schedule and protocol evaluations.

• Patients with a Karnofsky performance status score < 70.

• Subjects who fail to meet the HIV treatment criteria (CD4 and viral load) indicated above.