A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

HIV Infections Clinical Trial

Official title:

A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002333
• Other study ID #: 229A
• Secondary ID: NV 14256BNV 1425
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1995
• 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

To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).

Description:

Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• G-CSF and erythropoietin.

• Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.

Concurrent Treatment:

Allowed:

• Limited localized radiation therapy to the skin.

Patients must have:

• Documented HIV infection.

• CD4 count 50 - 300 cells/mm3.

• Received prior AZT that has been discontinued at least 28 days prior to study entry.

• No active opportunistic infection requiring immediate treatment.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Signs or symptoms of peripheral neuropathy.

• Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.

• Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.

• Any grade 3 or worse laboratory or clinical abnormality.

• Inability to comply with protocol requirements.

Concurrent Medication:

Excluded:

• Other antiretroviral drugs.

• Experimental drugs.

• Nephrotoxic or hepatotoxic drugs.

• Drugs likely to cause peripheral neuropathy.

• Antineoplastic agents.

• Biologic response modifiers.

Concurrent Treatment:

Excluded:

• Radiation therapy other than limited localized therapy to skin.

Patients with the following prior conditions are excluded:

• History of non-Hodgkin's lymphoma.

• Unexplained fever >= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.

• Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.

• History of grade 2 or worse peripheral neuropathy.

Prior Medication:

Excluded:

• Prior HIV proteinase inhibitor.

• Prior antiretroviral therapy other than AZT.

• Acute therapy for opportunistic infection within 14 days prior to study entry.

Prior Treatment:

Excluded:

• More than 3 units of blood in any 21-day period within 3 months prior to study entry.

Required:

• Prior AZT.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Saquinavir

• Zalcitabine

Locations

Country	Name	City	State
Canada	Southern Alberta HIV Clinic	Calgary	Alberta
Canada	McMaster Univ Med Ctr	Hamilton	Ontario
Canada	Clinique Medicale L'Actuele	Montreal	Quebec
Canada	Montreal Gen Hosp	Montreal	Quebec
Canada	Sunnybrook Health Science Ctr	Toronto	Ontario
Puerto Rico	San Juan Veterans Administration Med Ctr	San Juan
United States	Albany Med College	Albany	New York
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	West Paces Clinical Research Incoporated	Atlanta	Georgia
United States	Massachusetts Gen Hosp / Harvard Med School	Boston	Massachusetts
United States	New England Deaconess Hosp	Boston	Massachusetts
United States	New England Med Ctr	Boston	Massachusetts
United States	UMDNJ - New Jersey Med School / Cooper Hosp	Camden	New Jersey
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	Oaklawn Physicians Group	Dallas	Texas
United States	Harper Hosp	Detroit	Michigan
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Kaiser Foundation Hosp	Harbor City	California
United States	Baylor College of Medicine	Houston	Texas
United States	UCSD	La Jolla	California
United States	CARE Ctr / UCLA Med Ctr	Los Angeles	California
United States	UCLA School of Medicine	Los Angeles	California
United States	Univ of Tennessee	Memphis	Tennessee
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Univ of Miami Dept of Medicine	Miami	Florida
United States	Stratogen of South Florida	Miami Beach	Florida
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Beth Israel Med Ctr	New York	New York
United States	Harkness Pavilion	New York	New York
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	UMDNJ - New Jersy Med School	Newark	New Jersey
United States	Graduate Hosp / Tuttleman Cancer Ctr	Philadelphia	Pennsylvania
United States	Thomas Jefferson Med College	Philadelphia	Pennsylvania
United States	Oregon Health Sciences Univ	Portland	Oregon
United States	UCD	Sacramento	California
United States	Davies Med Ctr / c/o HIV Institute	San Francisco	California
United States	Mount Zion Med Ctr / UCSF	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Univ of Washington / Harborview Med Ctr	Seattle	Washington
United States	Pacific Oaks Med Group / Rsch & Scientific Investigation	Sherman Oaks	California
United States	Washington Univ School of Medicine	St. Louis	Missouri
United States	Sunnyvale Med Clinic	Sunnyvale	California
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Veterans Administration Med Ctr	Washington	District of Columbia
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

Revicki DA, Swartz C, Wu AW, Haubrich R, Collier AC. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir plus zalcitabine therapy for adults with advanced HIV infection with CD4 counts between 50 and 300 cells/mm3. Antivir Ther. 1999;4(1):35-44. — View Citation