Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
An Open-label Study Evaluating the Resistance Profile of Single Dose Nevirapine(NVP) When Combined With a 4 or 7 Day Course of Combivir® (ZDV/3TC) Compared to Single Dose Nevirapine for the Prevention of Mother to Child Transmission (pMTCT) of HIV - Treatment Options Preservation Study (T.O.P.S.)
To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to child transmission can reduce the rate of development of drug resistant mutations of HIV-1, in HIV-1 infected pregnant women, who have not received antiretroviral therapy previously.
An open-label, randomised, multicentre study to determine whether a regimen of single dose
nevirapine combined with either 4 or 7 days of Combivir, compared to a regimen of single
dose nevirapine, for the prevention of mother to child transmission can reduce the rate of
development of drug resistant mutations of HIV-1, in HIV-1 infected pregnant women, who have
not received antiretroviral therapy previously.
An interim analysis of the first 61 patients showed that a clinical and statistical
difference exists between the occurrence of HIV-1 NNRTI resistant mutations in the single
dose nevirapine only arm (50%) and the two other combination arms (9%). These findings
partially answered the objectives outlined in the initial objectives. Consequently enrolment
onto the single dose nevirapine arm was terminated. The objective of the trial was modified
to compare whether either the 4 or the 7 day combination of ZDV+3TC and nevirapine would
result in any significant reduction in the incidence of nevirapine resistance.
Study Hypothesis:
Evaluations of HIV-1 resistance patterns in trials of pMTCT have demonstrated nevirapine
resistant HIV-1 isolates in approximately 15-20% of mothers 4-6 weeks after receiving either
a single or two dose 200mg nevirapine regimen. Although the ability to detect these
genotypic mutations decreases to 0% by about 18 months, it is not clear whether this
resistance is clinically significant.(HIVNET 012).
Empirically then it would seem useful to develop a strategy to diminish the emergence of
this early resistance, therefore this study is proposed to evaluate whether the effect of 4
or 7 days of 3TC+ ZDV added to a single dose nevirapine regimen for the prevention of MTCT
will prevent the emergence of resistance to nevirapine.
Comparison(s):
ACTG 076, Thai, PETRA , HIVNET 006/012, SAINT
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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