Clinical trial NCT00002333: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Zalcitabine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Saquinavir
HIV Protease Inhibitors
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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).

Detailed 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.)

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Harbor City
country: United States
facility: Kaiser Foundation Hosp
state: California
city: La Jolla
country: United States
facility: UCSD
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Los Angeles
country: United States
facility: CARE Ctr / UCLA Med Ctr
state: California
city: Sacramento
country: United States
facility: UCD
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr / c/o HIV Institute
state: California
city: San Francisco
country: United States
facility: Mount Zion Med Ctr / UCSF
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group / Rsch & Scientific Investigation
state: California
city: Sunnyvale
country: United States
facility: Sunnyvale Med Clinic
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Miami Beach
country: United States
facility: Stratogen of South Florida
state: Florida
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Miami
country: United States
facility: Univ of Miami Dept of Medicine
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: West Paces Clinical Research Incoporated
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: New Orleans
country: United States
facility: Tulane Univ Med School
state: Louisiana
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Gen Hosp / Harvard Med School
state: Massachusetts
city: Boston
country: United States
facility: New England Deaconess Hosp
state: Massachusetts
city: Detroit
country: United States
facility: Harper Hosp
state: Michigan
city: St. Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Camden
country: United States
facility: UMDNJ - New Jersey Med School / Cooper Hosp
state: New Jersey
city: Newark
country: United States
facility: UMDNJ - New Jersy Med School
state: New Jersey
city: Albany
country: United States
facility: Albany Med College
state: New York
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Saint Vincent's Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: Harkness Pavilion
state: New York
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson Med College
state: Pennsylvania
city: Philadelphia
country: United States
facility: Graduate Hosp / Tuttleman Cancer Ctr
state: Pennsylvania
city: Memphis
country: United States
facility: Univ of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: Oaklawn Physicians Group
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Univ of Washington / Harborview Med Ctr
state: Washington
city: Calgary
country: Canada
facility: Southern Alberta HIV Clinic
state: Alberta
city: Hamilton
country: Canada
facility: McMaster Univ Med Ctr
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Ctr
state: Ontario
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
city: Montreal
country: Canada
facility: Montreal Gen Hosp
state: Quebec
city: San Juan
country: Puerto Rico
facility: San Juan Veterans Administration Med Ctr
Study officials:
References:
citation: Revicki D, Swartz C. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir-zalcitabine therapy for advanced HIV-infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:113 (abstract no 266)