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

June 20, 2008
July 7, 2008
November 2004
December 2009   (final data collection date for primary outcome measure)
number of patients with undetectable plasma HIV-1 viral load [ Time Frame: 240 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00703898 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Durability of Nevirapine-Based Antiretroviral Regimen
Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: nevirapine
200 mg/day twice a day
Other Name: GPO-vir
Not Provided
Manosuthi W, Tantanathip P, Prasithisirikul W, Likanonsakul S, Sungkanuparph S. Durability of stavudine, lamivudine and nevirapine among advanced HIV-1 infected patients with/without prior co-administration of rifampicin: a 144-week prospective study. BMC Infect Dis. 2008 Oct 14;8:136.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00703898
0327/3619
Yes
Weerawat Manosuthi, Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
Not Provided
Principal Investigator: Weerawat Manosuthi Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP