Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
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.
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.
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When a drug leading to selection of a resistant viral population is withdrawn the original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
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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