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Torrance, California 90509

  • HIV Infections

Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00004852


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Torrance, California 90509
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 30, 2021

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