NCT00144157

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

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 regimen of nevirapine and ZDV+3TC treatment. As well as to evaluate the proportion of patients who fail this treatment at 24 and 48 weeks, and to evaluate the resistance profile of HIV isolates from patients who fail nevirapine and ZDV+3TC treatment. Study Hypothesis: When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus, over time, becomes the predominant virus again. However, low frequency (below level of detection) of drug resistant viral sub-populations may be retained which could mean that the drug resistant variant might reappear rapidly should the same drug be reintroduced as part of combination therapy at a later stage.Therefore this study is proposed to evaluate whether there is an impact of single dose nevirapine for the prevention of MTCT on the subsequent response to a standard HAART regimen that contains nevirapine. Comparison(s): trial 1100.1090

Conditions

• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DRUG	Nevirapine
DRUG	Zidovudine
DRUG	3TC

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-09-05
• Last updated: 2013-11-14

Locations

3 sites across 1 country: South Africa