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

This study is ongoing, but not recruiting participants.

First Received: April 7, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005118

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Ritonavir	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Indinavir Ritonavir Indinavir Sulfate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

100

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005118

Show 40 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Study ID Numbers:	246V, CRX481, 107-00
Study First Received:	April 7, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005118 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Indinavir

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
HIV Protease Inhibitors

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 09, 2009