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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Saquinavir
Zalcitabine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Foundation Hosp
  • UCSD
  • UCLA School of Medicine
  • CARE Ctr / UCLA Med Ctr
  • UCD
  • UCSF - San Francisco Gen Hosp
  • Davies Med Ctr / c/o HIV Institute
  • Mount Zion Med Ctr / UCSF
  • San Francisco Veterans Administration Med Ctr
  • Pacific Oaks Med Group / Rsch & Scientific Investigation
  • Sunnyvale Med Clinic
  • Harbor - UCLA Med Ctr
  • Veterans Administration Med Ctr
  • Stratogen of South Florida
  • Miami Veterans Administration Med Ctr
  • Univ of Miami Dept of Medicine
  • AIDS Research Consortium of Atlanta
  • West Paces Clinical Research Incoporated
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Univ of Kansas School of Medicine
  • Tulane Univ Med School
  • New England Med Ctr
  • Massachusetts Gen Hosp / Harvard Med School
  • New England Deaconess Hosp
  • Harper Hosp
  • Washington Univ School of Medicine
  • UMDNJ - New Jersey Med School / Cooper Hosp
  • UMDNJ - New Jersy Med School
  • Albany Med College
  • Beth Israel Med Ctr
  • Saint Vincent's Hosp and Med Ctr
  • Harkness Pavilion
  • Ohio State Univ Hosp
  • Oregon Health Sciences Univ
  • Thomas Jefferson Med College
  • Graduate Hosp / Tuttleman Cancer Ctr
  • Univ of Tennessee
  • Oaklawn Physicians Group
  • Univ TX Galveston Med Branch
  • Baylor College of Medicine
  • Univ of Washington / Harborview Med Ctr
  • Southern Alberta HIV Clinic
  • McMaster Univ Med Ctr
  • Sunnybrook Health Science Ctr
  • Clinique Medicale L'Actuele
  • Montreal Gen Hosp
  • San Juan Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002333
Brief Title
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

2. Study Status

Record Verification Date
February 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
900 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kaiser Foundation Hosp
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
920930679
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
900121973
Country
United States
Facility Name
CARE Ctr / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCD
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Davies Med Ctr / c/o HIV Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Mount Zion Med Ctr / UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Pacific Oaks Med Group / Rsch & Scientific Investigation
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Sunnyvale Med Clinic
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Stratogen of South Florida
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Univ of Miami Dept of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
West Paces Clinical Research Incoporated
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts Gen Hosp / Harvard Med School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New England Deaconess Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
UMDNJ - New Jersey Med School / Cooper Hosp
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
UMDNJ - New Jersy Med School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harkness Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Thomas Jefferson Med College
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Graduate Hosp / Tuttleman Cancer Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Oaklawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550882
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Univ of Washington / Harborview Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Southern Alberta HIV Clinic
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
McMaster Univ Med Ctr
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Gen Hosp
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
San Juan Veterans Administration Med Ctr
City
San Juan
ZIP/Postal Code
009275800
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
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)
Results Reference
background

Learn more about this trial

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

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