A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs - 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 NCT00002407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs
Official Title ^ICMJE	A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3
Brief Summary	The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.
Detailed Description	In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens: Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine
Study Arms / Comparison Groups
Publications *	Norton M. Choosing the right initial antiretroviral regimens. GMHC Treat Issues. 1999 Feb;13(2):7-10. No abstract available.
* 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: Diagnosed asymptomatic HIV infection. HIV-1 RNA greater than 500 copies/ml. CD4+ T-cell count greater than 200/mm3. Never received antiretroviral therapy. Exclusion Criteria Co-existing Condition: Excluded: Severe non-HIV-related disease. Patients with the following prior conditions are excluded: History of neuropathy. Prior Medication: Excluded: Investigational drug within 1 month prior to study. Immunomodulatory drug within 1 month prior to study. Prior Treatment: Excluded: Radiation therapy within past month. Chemotherapy within past month.
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	NCT00002407
Responsible Party
Study ID Numbers ^ICMJE	ATLANTIC STUDY
Study Sponsor ^ICMJE	Weill Medical College of Cornell University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1998
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP