DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017