Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Glaxo Wellcome
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
