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Durability of Nevirapine-Based Antiretroviral Regimen

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
nevirapine
Sponsored by
Bamrasnaradura Infectious Diseases Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, nevirapine, durability, AIDS, Treatment Naïve

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, Bamrasnaradura Infectious Diseases Institute

Outcomes

Primary Outcome Measures

number of patients with undetectable plasma HIV-1 viral load

Secondary Outcome Measures

Full Information

First Posted
June 20, 2008
Last Updated
July 7, 2008
Sponsor
Bamrasnaradura Infectious Diseases Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00703898
Brief Title
Durability of Nevirapine-Based Antiretroviral Regimen
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2009 (undefined)
Study Completion Date
April 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bamrasnaradura Infectious Diseases Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, nevirapine, durability, AIDS, Treatment Naïve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nevirapine
Other Intervention Name(s)
GPO-vir
Intervention Description
200 mg/day twice a day
Primary Outcome Measure Information:
Title
number of patients with undetectable plasma HIV-1 viral load
Time Frame
240 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weerawat Manosuthi
Organizational Affiliation
Bamrasnaradura Infectious Diseases Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Bamrasnaradura Infectious Diseases Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18851761
Citation
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.
Results Reference
derived

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Durability of Nevirapine-Based Antiretroviral Regimen

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