Beverly Hills, California 90211

  • 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.


Study is Available At:


Original ID:

225D


NCT ID:

NCT00004852


Secondary ID:

EPV2000 1


Study Acronym:


Brief Title:

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 Ha


Official Title:

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 Antiretr


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:September 1999
Verification Date:August 2000
Last Changed Date:June 23, 2005
First Received Date:March 2, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Zidovudine
Intervention Type:Drug
Name:Lamivudine
Intervention Type:Drug
Name:Efavirenz

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glaxo Wellcome

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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