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
NCT ID: NCT00002333
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
900 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saquinavir
Zalcitabine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Foundation Hosp
Harbor City, California, United States
UCSD
La Jolla, California, United States
UCLA School of Medicine
Los Angeles, California, United States
CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States
UCD
Sacramento, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, 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
Pacific Oaks Med Group / Rsch & Scientific Investigation
Sherman Oaks, California, United States
Sunnyvale Med Clinic
Sunnyvale, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 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
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
West Paces Clinical Research Incoporated
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
New England Med Ctr
Boston, Massachusetts, United States
Massachusetts Gen Hosp / Harvard Med School
Boston, Massachusetts, United States
New England Deaconess Hosp
Boston, Massachusetts, United States
Harper Hosp
Detroit, Michigan, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, United States
UMDNJ - New Jersy Med School
Newark, New Jersey, United States
Albany Med College
Albany, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
Harkness Pavilion
New York, New York, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
Oregon Health Sciences Univ
Portland, Oregon, United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, United States
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, United States
Univ of Tennessee
Memphis, Tennessee, United States
Oaklawn Physicians Group
Dallas, Texas, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Univ of Washington / Harborview Med Ctr
Seattle, Washington, United States
Southern Alberta HIV Clinic
Calgary, Alberta, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
San Juan Veterans Administration Med Ctr
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NV 14256B
Identifier Type: -
Identifier Source: secondary_id
NV 14256A
Identifier Type: -
Identifier Source: secondary_id
229A
Identifier Type: -
Identifier Source: org_study_id