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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00002452

Collaborator

(none)

Enrollment

Locations

3.8

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: L-756423 Drug: Indinavir sulfate	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	352942050
2	Georgetown Univ	Washington	District of Columbia	United States	20007
3	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
4	Hawaii AIDS Clinical Trial Unit	Honolulu	Hawaii	United States	96816
5	The CORE Ctr	Chicago	Illinois	United States	60612
6	Cornell Clinical Trials Unit - Chelsea Clinic	New York	New York	United States	10011
7	Pittsburgh Treatment Ctr / Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
8	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37203