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Durability of Nevirapine-Based Antiretroviral Regimen

NCT ID: NCT00703898

Last Updated: 2008-07-08

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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV nevirapine durability AIDS Treatment Naïve

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

Sponsors

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Bamrasnaradura Infectious Diseases Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bamrasnaradura Infectious Diseases Institute

Principal Investigators

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Weerawat Manosuthi

Role: PRINCIPAL_INVESTIGATOR

Bamrasnaradura Infectious Diseases Institute

Locations

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Department of Medicine, Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 18851761 (View on PubMed)

Other Identifiers

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0327/3619

Identifier Type: -

Identifier Source: org_study_id