HIV Infections
Conditions
Keywords
HIV, nevirapine, durability, AIDS, Treatment Naïve
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.
Interventions
DRUGnevirapine
200 mg/day twice a day
Sponsors
Bamrasnaradura Infectious Diseases Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with undetectable plasma HIV-1 viral load | 240 weeks |
Countries
Thailand
Outcome results
None listed