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
1 other identifier
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Nov 2004
Longer than P75 for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 8, 2008
June 1, 2008
5.1 years
June 20, 2008
July 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients with undetectable plasma HIV-1 viral load
240 weeks
Interventions
Eligibility Criteria
You may qualify if:
- HIV-infected individuals ≥15 years of age
- CD4 cell count \<350 cells/mm3
- Willing to participate and give consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, 11000, Thailand
Related Publications (1)
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. doi: 10.1186/1471-2334-8-136.
PMID: 18851761DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weerawat Manosuthi
Bamrasnaradura Infectious Diseases Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 24, 2008
Study Start
November 1, 2004
Primary Completion
December 1, 2009
Study Completion
April 1, 2010
Last Updated
July 8, 2008
Record last verified: 2008-06