A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive 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 NCT00002236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
Official Title ^ICMJE	An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals
Brief Summary	The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.
Detailed Description	Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Delavirdine mesylate 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	32
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml. Have a CD4 cell count of at least 50 cells/mm3. Are at least 14 years old (consent of parent or guardian is required if under 18). Exclusion Criteria You will not be eligible for this study if you: Have ever taken an anti-HIV drug other than ZDV. Have taken ZDV for more than 1 month.
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	NCT00002236
Responsible Party
Study ID Numbers ^ICMJE	228G, M/3331/0072
Study Sponsor ^ICMJE	Pharmacia and Upjohn
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP