A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002452

First received: January 17, 2000

Last updated: June 23, 2005

Last verified: February 2000

History of Changes

Tracking Information
First Received Date ^ICMJE	January 17, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
Official Title ^ICMJE	A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen
Brief Summary	The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
Detailed Description	All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: L-756423 Drug: Indinavir sulfate
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Are at least 18 years old. Have a viral load of at least 1,000 copies/ml. Have a CD4 cell count of at least 100 cells/mm3. Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir. Exclusion Criteria You will not be eligible for this study if you: Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
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 Number ^ICMJE	NCT00002452
Other Study ID Numbers ^ICMJE	300A, 008-00
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	February 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top