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Durability of Nevirapine-Based Antiretroviral Regimen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703898
First Posted: June 24, 2008
Last Update Posted: July 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bamrasnaradura Infectious Diseases Institute
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 20, 2008
First Posted: June 24, 2008
Last Update Posted: July 8, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers


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