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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Saquinavir (Drug); Zalcitabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche


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).

Clinical Details

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

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.)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.


- Prior AZT.

Locations and Contacts

San Juan Veterans Administration Med Ctr, San Juan 009275800, Puerto Rico

Southern Alberta HIV Clinic, Calgary, Alberta, Canada

Kaiser Foundation Hosp, Harbor City, California 90710, United States

UCSD, La Jolla, California 920930679, United States

CARE Ctr / UCLA Med Ctr, Los Angeles, California 90095, United States

UCLA School of Medicine, Los Angeles, California 900121973, United States

UCD, Sacramento, California 95817, United States

Davies Med Ctr / c/o HIV Institute, San Francisco, California 94114, United States

Mount Zion Med Ctr / UCSF, San Francisco, California 94115, United States

San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States

UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States

Pacific Oaks Med Group / Rsch & Scientific Investigation, Sherman Oaks, California 91403, United States

Sunnyvale Med Clinic, Sunnyvale, California 94086, United States

Harbor - UCLA Med Ctr, Torrance, California 90505, United States

Veterans Administration Med Ctr, Washington, District of Columbia 20422, United States

Stratogen of South Florida, Miami Beach, Florida 33140, United States

Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States

Univ of Miami Dept of Medicine, Miami, Florida 33136, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

West Paces Clinical Research Incoporated, Atlanta, Georgia 30327, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States

Tulane Univ Med School, New Orleans, Louisiana 70112, United States

Massachusetts Gen Hosp / Harvard Med School, Boston, Massachusetts 02114, United States

New England Deaconess Hosp, Boston, Massachusetts 02215, United States

New England Med Ctr, Boston, Massachusetts 02111, United States

Harper Hosp, Detroit, Michigan 48201, United States

Washington Univ School of Medicine, St. Louis, Missouri 63108, United States

UMDNJ - New Jersey Med School / Cooper Hosp, Camden, New Jersey 08103, United States

UMDNJ - New Jersy Med School, Newark, New Jersey 08103, United States

Albany Med College, Albany, New York 12208, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Harkness Pavilion, New York, New York 10032, United States

Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States

Ohio State Univ Hosp, Columbus, Ohio 43210, United States

McMaster Univ Med Ctr, Hamilton, Ontario, Canada

Sunnybrook Health Science Ctr, Toronto, Ontario, Canada

Oregon Health Sciences Univ, Portland, Oregon 97201, United States

Graduate Hosp / Tuttleman Cancer Ctr, Philadelphia, Pennsylvania 19146, United States

Thomas Jefferson Med College, Philadelphia, Pennsylvania 19107, United States

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

Montreal Gen Hosp, Montreal, Quebec, Canada

Univ of Tennessee, Memphis, Tennessee 38163, United States

Oaklawn Physicians Group, Dallas, Texas 75219, United States

Univ TX Galveston Med Branch, Galveston, Texas 775550882, United States

Baylor College of Medicine, Houston, Texas 77005, United States

Univ of Washington / Harborview Med Ctr, Seattle, Washington 98104, United States

Additional Information

Related publications:

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.

Last updated: June 23, 2005

Page last updated: August 23, 2015

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