Durability of Nevirapine-Based Antiretroviral Regimen

Bamrasnaradura Infectious Diseases Institute

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: nevirapine

Study type: Interventional

Funder types: Other

Identifiers

NCT00703898

0327/3619

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)