Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004852
First received: March 2, 2000
Last updated: June 23, 2005
Last verified: August 2000

March 2, 2000
June 23, 2005
September 1999
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Complete list of historical versions of study NCT00004852 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Efavirenz
  • Drug: Lamivudine
  • Drug: Zidovudine
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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 18 years of age or older.
  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
  • Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
  • Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken any antiretroviral (anti-HIV) agent.
  • Are pregnant or breast-feeding.
  • Are unable to absorb food or have trouble taking medicines by mouth.
  • Abuse alcohol or drugs to an extent that may make study participation difficult.
  • Are not likely to be able to complete the 48 weeks of study treatment.
  • Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
  • Have received an investigational vaccine within the past 3 months or have received gene therapy.
  • Have a severe medical condition such as diabetes or heart trouble.
  • Have been diagnosed with AIDS.
  • Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
  • Are taking medications that affect the immune system within 30 days of study entry.
  • Are taking medications that may interact with the study drugs.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Puerto Rico
 
NCT00004852
225D, EPV2000 1
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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