Status:
COMPLETED
Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Acquired Immunodeficiency Syndrome
Eligibility:
FEMALE
19-45 years
Phase:
PHASE4
Brief 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.
Detailed Description
An open-label, single arm, multicentre study to determine the virologic and immunologic responsiveness of women, who previously received a regimen of nevirapine for the prevention of MTCT, to a regime...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00144157
Start Date
June 1 2003
End Date
July 1 2006
Last Update
November 14 2013
Active Locations (3)
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1
Boehringer Ingelheim Investigational Site
Capetown, South Africa, 7925
2
Boehringer Ingelheim Investigational Site
Parow, South Africa, 7505
3
Boehringer Ingelheim Investigational Site
Soweto, South Africa, 2013