A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002442
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2000

November 2, 1999
June 23, 2005
June 1999
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Complete list of historical versions of study NCT00002442 on ClinicalTrials.gov Archive Site
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A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection

The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.

Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Nelfinavir mesylate
  • Drug: Lamivudine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are at least 18 years old.
  • Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
  • Have a CD4 cell count of at least 50 cells/mm3.
  • Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
  • Agree to abstain from sex or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a history of an AIDS-defining illness or certain other medical conditions.
  • Are allergic to any of the study drugs.
  • Are unable to take medication by mouth for any reason.
  • Have received certain medications.
  • Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
  • Are pregnant or breast-feeding.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002442
225C, COLA 4005
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
August 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP