Durability of Nevirapine-Based Antiretroviral Regimen
Phase 4
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00703898
- Lead Sponsor
- Bamrasnaradura Infectious Diseases Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method number of patients with undetectable plasma HIV-1 viral load 240 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Medicine, Bamrasnaradura Infectious Diseases Institute
🇹🇭Nonthaburi, Thailand