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 - Tabular View

Tracking Information
First Received Date ^ICMJE	March 2, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00004852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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 Antiretroviral-Naive Adults With HIV-1 Infection
Brief 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.
Detailed Description	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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Efavirenz Drug: Lamivudine Drug: Zidovudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Brazil, Canada, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00004852
Responsible Party
Study ID Numbers ^ICMJE	225D, EPV2000 1
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP