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CompletedNCT00703898Updated Jul 8, 2008

Durability of Nevirapine-Based Antiretroviral Regimen

A Phase 4 interventional study of nevirapine in HIV Infections, sponsored by Bamrasnaradura Infectious Diseases Institute. Completed at 1 site in Thailand. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2008-07-08.

Sponsored by Bamrasnaradura Infectious Diseases Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
15 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • HIV Infections

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Keywords

  • HIV
  • nevirapine
  • durability
  • AIDS
  • Treatment Naïve
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 140 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Bamrasnaradura Infectious Diseases Institute is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HIV-infected individuals ≥15 years of age
  • CD4 cell count \<350 cells/mm3
  • Willing to participate and give consent form

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (actual)

Interventions

  • Drugnevirapine

    200 mg/day twice a day

    Also known as: GPO-vir

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What researchers measure

Primary outcomes

  1. number of patients with undetectable plasma HIV-1 viral load

    Time frame: 240 weeks

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Study locations

1 site
  • Department of Medicine, Bamrasnaradura Infectious Diseases Institute
    Nonthaburi, 11000, Thailand
08

References and documents

Publications

  • 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. PubMed 18851761 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00703898
Lead sponsor
Bamrasnaradura Infectious Diseases Institute
First posted
Jun 24, 2008
Start date
Nov 2004
Primary completion
Dec 2009
Completion
Apr 2010
Last update
Jul 8, 2008

Study contacts

Weerawat Manosuthi
principal investigator · Bamrasnaradura Infectious Diseases Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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