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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00004852

Run by

Glaxo Wellcome

Starts

1999-09-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Pacific Oaks Research — Beverly Hills, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Tower ID Med Associates — Los Angeles, California, United States
• Davies Med Ctr / c/o HIV Institute — San Francisco, California, United States
• Kaiser Foundation Hospital — San Francisco, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Bach and Godofsky — Bradenton, Florida, United States
• TheraFirst Med Ctrs Inc — Fort Lauderdale, Florida, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• The Coleman Institute Inc — Fort Lauderdale, Florida, United States
• The Coleman Institute Inc — Ft. Pierce, Florida, United States
• Kaiser Permanente Infectious Diseases — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Infectious Disease of Indiana — Indianapolis, Indiana, United States
• Univ of Kentucky Med Ctr — Lexington, Kentucky, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Boston Med Ctr / Evans - 556 — Boston, Massachusetts, United States
• Antibiotic Research Associates — Kansas City, Missouri, United States
• East Orange Veterans Administration Med Ctr — East Orange, New Jersey, United States
• ID Care Inc — New Brunswick, New Jersey, United States
• ID Care Inc — Princeton, New Jersey, United States
• Phoenix Body Positive — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.