A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)

Sponsor

Agouron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002170

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections	Drug: Nelfinavir mesylate	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

HIV infection
New diagnosis of MAC bacteremia and < 7 days of therapy.

Prior Medication:

Allowed:

Patients no more than 7 days of therapy for MAC disease.

Exclusion Criteria

Prior Medication:

Excluded:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	92103
2	Harbor UCLA Med Ctr	Torrance	California	United States	90502
3	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
4	Boston VA Med Ctr / 151	Boston	Massachusetts	United States	02730
5	Baylor Univ	Houston	Texas	United States	77009