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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Efavirenz
* Drug: Lamivudine
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Efavirenz|nan|
|Drug: Lamivudine|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, Genotype, Phenotype, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz