A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients - 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 NCT00002401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
Official Title ^ICMJE	An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals
Brief Summary	The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
Detailed Description	In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks: Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC. Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Delavirdine mesylate 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	160
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine. Exclusion Criteria Prior Medication: Excluded: Prior indinavir. Prior lamivudine. Prior protease inhibitors. Prior non-nucleoside reverse transcriptase inhibitors. 1 month or more prior zidovudine. 1. HIV-1 positive. CD4 coun tis above 50. HIV-1 RNA levels greater than 20,000.
Gender	Both
Ages	14 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	NCT00002401
Responsible Party
Study ID Numbers ^ICMJE	228F, 0074
Study Sponsor ^ICMJE	Pharmacia and Upjohn
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	January 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP