A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment
Official Title ^ICMJE	A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients.
Brief Summary	The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.
Detailed Description	In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens: Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate
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 must have: CD4 count > 50. HIV RNA > 5,000. No active AIDS (excluding CD4 count < 200). Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: 3TC or any protease inhibitor, if < 1 week of therapy. Other nucleoside analogs, if < 4 weeks of therapy. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Active AIDS (not including CD4 count < 200). Malabsorption syndrome affecting drug absorption. Concurrent Medication: Excluded: Enrollment in any other investigational drug protocol. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors.
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

Administrative Information
NCT ID ^ICMJE	NCT00002216
Responsible Party
Study ID Numbers ^ICMJE	280C, UNAP 11, NZTA 4002
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP