Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs - Tabular View

Tracking Information
First Received Date ^ICMJE	March 2, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	February 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00011895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title ^ICMJE	A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects
Brief Summary	The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
Detailed Description	Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone. An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Efavirenz
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	Active, not recruiting
Enrollment ^ICMJE	400
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients may be eligible for this study if they: Are at least 13 years old. Are HIV-positive. Have a viral load of at least 5,000 copies/ml. Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate. Provide written consent of a parent or guardian, if under 18 years of age. Exclusion Criteria Patients will not be eligible for this study if they: Have taken nonnucleoside reverse transcriptase inhibitors. Have taken other anti-HIV drugs for 2 weeks or more. Have an opportunistic (AIDS-related) infection. Are pregnant or breast-feeding. Have had hepatitis within the past 6 months. Are allergic to the study drugs or their ingredients. Have a mental, physical, or substance abuse disorder. Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease. Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth. Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons). Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period. Require foscarnet or other drugs that are shown to be effective against HIV. Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives. Are taking experimental drugs. Are unlikely to complete the study or take the drugs.
Gender	Both
Ages	13 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

Administrative Information
NCT ID ^ICMJE	NCT00011895
Responsible Party
Study ID Numbers ^ICMJE	308B, ESS40013
Study Sponsor ^ICMJE	GlaxoSmithKline
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP