Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00001040

Collaborator

(none)

300

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC.

SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Saquinavir Drug: Zidovudine Drug: Zalcitabine	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Actual Primary Completion Date :

May 1, 1994

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Prior Medication: Required:

At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.

Patients must have:

HIV seropositivity.
Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
CD4 count > 50 to <= 300 cells/mm3.
Life expectancy of at least 6 months.
Prior AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
Known intolerance to Ro 31-8959, AZT, or ddC.
Symptoms suggestive of pancreatitis.
Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
Visceral Kaposi's sarcoma.
Lymphoma that will require therapy within the next 6 months.
Transfusion dependence.

Concurrent Medication:

Excluded:

Investigational or antineoplastic agents.

Concurrent Treatment:

Excluded:

Radiotherapy (other than local skin radiotherapy).
Transfusions.

Prior Medication:

Excluded:

Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry.
Prior treatment with an HIV proteinase inhibitor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Stanford Univ Med Ctr	Stanford	California	United States	943055107
3	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
4	Northwestern Univ Med School	Chicago	Illinois	United States	60611
5	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
6	Univ of Rochester Med Ctr	Rochester	New York	United States	14642
7	Ohio State Univ Hosp	Columbus	Ohio	United States	432101228
8	Girard Med Ctr	Philadelphia	Pennsylvania	United States	191046073
9	Univ TX Galveston Med Branch	Galveston	Texas	United States	775550882
10	Univ of Washington	Seattle	Washington	United States	98122