Durability of Nevirapine-Based Antiretroviral Regimen

This study has been completed.
Sponsor:
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT00703898
First received: June 20, 2008
Last updated: July 7, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: nevirapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

Primary Outcome Measures:
  • number of patients with undetectable plasma HIV-1 viral load [ Time Frame: 240 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: November 2004
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: nevirapine
    200 mg/day twice a day
    Other Name: GPO-vir
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703898

Locations
Thailand
Department of Medicine, Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Investigators
Principal Investigator: Weerawat Manosuthi Bamrasnaradura Infectious Diseases Institute
  More Information

No publications provided by Bamrasnaradura Infectious Diseases Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weerawat Manosuthi, Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier: NCT00703898     History of Changes
Other Study ID Numbers: 0327/3619
Study First Received: June 20, 2008
Last Updated: July 7, 2008
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Bamrasnaradura Infectious Diseases Institute:
HIV
nevirapine
durability
AIDS
Treatment Naïve

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014