Durability of Nevirapine-Based Antiretroviral Regimen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nevirapine

200 mg/day twice a day

Intervention Type DRUG

Other Intervention Names

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GPO-vir

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No