Durability of Nevirapine-Based Antiretroviral Regimen
Information source: Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: nevirapine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bamrasnaradura Infectious Diseases Institute Official(s) and/or principal investigator(s): Weerawat Manosuthi, Principal Investigator, Affiliation: Bamrasnaradura Infectious Diseases Institute
Summary
Although nevirapine is used as an alternative to efavirenz for initial regimen in developed
countries, nevirapine has still been a key antiretroviral drug in many resource-limited
countries including Thailand due to its accessibility and affordability. In addition, a
component of stavudine and lamivudine is still widely used as a backbone in the
antiretroviral regimen in this setting. To date, data on the durability of a regimen of
stavudine, lamivudine and nevirapine are very limited, particularly from the
resource-limited settings.
Clinical Details
Official title: Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: number of patients with undetectable plasma HIV-1 viral load
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HIV-infected individuals ≥15 years of age
- CD4 cell count <350 cells/mm3
- Willing to participate and give consent form
Exclusion Criteria:
- previous antiretroviral therapy
- pregnancy
- receiving a medication that has drug-drug interactions with NVP or RFP
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times of upper
limit of normal range
Locations and Contacts
Department of Medicine, Bamrasnaradura Infectious Diseases Institute, Nonthaburi 11000, Thailand
Additional Information
Starting date: November 2004
Last updated: July 7, 2008
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