The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

HIV Infections Clinical Trial

Official title:

A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005118
• Other study ID #: 246V
• Secondary ID: CRX481107-00
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 7, 2000
• Last updated: June 23, 2005

Study information

• Verified date: July 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.

Description:

Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are 18 years of age or older.

• Have a CD4 cell count of at least 50 cells/mm3.

• Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.

• Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.

• Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks.

• Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment.

• Are naive to at least one of the selected NRTIs.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

Locations

Country	Name	City	State
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Institute of Human Virology	Baltimore	Maryland
United States	Pacific Oaks Research	Beverly Hills	California
United States	Thomas Coffman MD	Boise	Idaho
United States	New England Med Ctr	Boston	Massachusetts
United States	Bronx Veterans Affairs Med Ctr	Bronx	New York
United States	Cooper Hospital Early Intervention Program	Camden	New Jersey
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Northwestern Univ / Infect Dis Div / Pasavant Pav 828	Chicago	Illinois
United States	The CORE Ctr	Chicago	Illinois
United States	Benjamin Young	Denver	Colorado
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Univ of Texas Med Branch / Div of Infectious Dis	Galveston	Texas
United States	Thomas Street Clinic	Houston	Texas
United States	Ocean View Internal Medicine	Long Beach	California
United States	Bisher Akil	Los Angeles	California
United States	Tower Infectious Diseases / Med Associates Inc	Los Angeles	California
United States	University of Louisville / ID Division	Louisville	Kentucky
United States	Mercer University School of Medicine	Macon	Georgia
United States	Mt Vernon Hosp	Mt. Vernon	New York
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	Bellevue Hosp Ctr	New York	New York
United States	Gramercy Park Physicians LLP	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	St Luke Roosevelt Hosp	New York	New York
United States	St Vincents Hosp / Clinical Research Program	New York	New York
United States	Oklahoma Univ Health Science Ctr	Oklahoma City	Oklahoma
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	Fanno Creek Clinic	Portland	Oregon
United States	Univ of Texas Health Sciences Ctr	San Antonio	Texas
United States	UCSD Med Ctr - Owen Clinic	San Diego	California
United States	HIV Institute / Davies Med Ctr	San Francisco	California
United States	San Francisco Veterans Adm Med Cntr	San Francisco	California
United States	Dr Ronald Nahass	Somerville	New Jersey
United States	SUNY at Stony Brook / Div of Infectious Disease	Stony Brook	New York
United States	Hillsborough County Health Dept	Tampa	Florida
United States	Avalar Medical Group	Tarzana	California
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Univ of Kansas School of Medicine	Wichita	Kansas
United States	Wake Forest Univ School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,