A Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Agouron Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002169

Purpose

The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are already being treated for cytomegalovirus (CMV) retinitis.

Condition	Intervention	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Nelfinavir mesylate	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Cytomegalovirus (CMV) Retinitis in AIDS Patients Who Are Receiving Standard Induction and Maintenance Therapy for This Infection

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV infection.
Newly diagnosed or first progression of CMV retinitis.

Exclusion Criteria

Prior Medication:

Excluded:

Prior therapy (or less than 2 weeks) with protease inhibitor other than saquinavir.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002169

Locations

United States, California
Univ of Southern California / LA County USC Med Cntr
Los Angeles, California, United States, 90033
Univ of California / UCI Med Ctr
Orange, California, United States, 92868
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 92103
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, District of Columbia
George Washington Univ
Washington, District of Columbia, United States, 20037
United States, Illinois
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611
United States, Texas
Univ of Texas Med Branch
Galveston, Texas, United States, 77555
Baylor Univ
Houston, Texas, United States, 77009

Sponsors and Collaborators

Agouron Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002169 History of Changes
Other Study ID Numbers:	259A, Study 517, AG1343-517
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Placebos
Antiviral Agents

Cytomegalovirus Retinitis
Treatment Outcome
Nelfinavir

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases

Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012