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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144183 |
A study that aims to show the resistance profile that develops in previously untreated populations that are given nevirapine only and nevirapine combined with Zidovudine and 3TC for the prevention of mother to child transmission. During an interim analysis it was discovered that the nevirapine-only treated patients showed more resistance than the combination-treated patients, and thus the nevirapine only arm of the study was discontinued. The study now monitors the resistance patterns of patients given nevirapine and ZDV+3TC for 4 versus 7 days.
Condition | Intervention | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome |
Drug: Nevirapine (NVP) Drug: Zidovudine (ZCV) Drug: 3TC |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Open Label Study of Single Dose NVP With 4 vs 7 Day Course of Combivir for pMTCT - Treatment Options Preservation Study (TOPS) |
Estimated Enrollment: | 407 |
Estimated Study Completion Date: | January 2007 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
South Africa | |
Boehringer Ingelheim Investigational Site | |
Soweto, South Africa, 2013 | |
Boehringer Ingelheim Investigational Site | |
Johannesburg, South Africa, 2093 | |
Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa, 7505 | |
Boehringer Ingelheim Investigational Site | |
Attridgeville, South Africa, 0081 | |
Boehringer Ingelheim Investigational Site | |
Durban, South Africa, 4001 |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. South Africa (Pty.) Ltd. |
Study ID Numbers: | 1100.1413, MCC;N2/19/8/2(1958) |
Study First Received: | September 2, 2005 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00144183 |
Health Authority: | South Africa: Medicines Control Council |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Disease Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Antiviral Agents |
Pharmacologic Actions Reverse Transcriptase Inhibitors Pathologic Processes Anti-Retroviral Agents Syndrome Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |