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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004852

Enrollment

Unknown

Registered

2001-08-31

Start date

1999-09-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, Genotype, Phenotype, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz

Brief summary

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

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.

Interventions

DRUGEfavirenz

DRUGLamivudine

DRUGZidovudine

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

Argentina, Brazil, Canada, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026