Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
An Open-Label Study of Nevirapine Plus Combivir® (ZDV+3TC) Treatment in Women Who Have Previously Received a Nevirapine Regimen for the Prevention of Mother to Child Transmission (pMTCT) of HIV-1.
1 other identifier
interventional
53
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2003
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedNovember 14, 2013
November 1, 2013
3.1 years
September 2, 2005
November 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients who fail to suppress viral load to 400c/mL or maintain a viral load 400 c/mL at 24 and 48 weeks. The mean change in HIV RNA measurement by 24 weeks.
Secondary Outcomes (1)
What type of resistance that develops Immunologic response to treatment Treatment safety Time to treatment and/or virologic failure 5.How many achieve viral loads<50c/mL
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Boehringer Ingelheim Investigational Site
Capetown, 7925, South Africa
Boehringer Ingelheim Investigational Site
Parow, 7505, South Africa
Boehringer Ingelheim Investigational Site
Soweto, 2013, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
B.I. South Africa (Pty.) Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
June 1, 2003
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
November 14, 2013
Record last verified: 2013-11