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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Efavirenz; Lamivudine; Zidovudine

Criteria

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.