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A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Saquinavir
Zidovudine
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 Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Saquinavir, HIV Protease Inhibitors

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin and G-CSF. Concurrent Treatment: Allowed: Local skin radiotherapy. Patients must have: HIV infection. CD4 count 50 - 350 cells/mm3. No prior antiretroviral therapy OR less than 16 weeks of prior AZT. No acute serious opportunistic infections requiring immediate treatment. No unexplained fever persisting for 14 days within 90 days prior to study entry. No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. Life expectancy of at least 80 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption. Severe chronic diarrhea. Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). Any grade 3 or worse toxicity. Inability to comply with study requirements. Concurrent Medication: Excluded: Other investigational agents. Antineoplastic agents. Biologic response modifiers (including interferons). Foscarnet. Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: Acute therapy for opportunistic infection within 14 days prior to study entry. Prior HIV proteinase inhibitor.

Sites / Locations

  • Phoenix Body Positive
  • UCD Med Ctr
  • Davies Med Ctr
  • Mount Zion Med Ctr / UCSF
  • Pacific Oaks Med Group
  • Sunnyvale Med Clinic
  • Novum Inc
  • Howard Univ
  • Miami Veterans Administration Med Ctr
  • Univ of Miami School of Medicine
  • Cook County Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Tulane Univ Med School
  • Massachusetts Gen Hosp
  • HIV Wellness Ctr / Univ Med Ctr
  • Beth Israel Med Ctr
  • Harkness Pavilion
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Univ of Oklahoma Health Science / Pharmacy Practice
  • Novum Inc
  • Respiratory Associates
  • N Texas Ctr for AIDS & Clin Rsch
  • Univ TX Galveston Med Branch
  • Thomas Street Clinic / Baylor College of Medicine
  • Univ of Washington
  • 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
NCT00002334
Brief Title
A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment
Official Title
A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3
Study Type
Interventional

2. Study Status

Record Verification Date
September 1996
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, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
Detailed Description
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
3000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Zidovudine
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: Erythropoietin and G-CSF. Concurrent Treatment: Allowed: Local skin radiotherapy. Patients must have: HIV infection. CD4 count 50 - 350 cells/mm3. No prior antiretroviral therapy OR less than 16 weeks of prior AZT. No acute serious opportunistic infections requiring immediate treatment. No unexplained fever persisting for 14 days within 90 days prior to study entry. No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. Life expectancy of at least 80 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption. Severe chronic diarrhea. Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). Any grade 3 or worse toxicity. Inability to comply with study requirements. Concurrent Medication: Excluded: Other investigational agents. Antineoplastic agents. Biologic response modifiers (including interferons). Foscarnet. Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: Acute therapy for opportunistic infection within 14 days prior to study entry. Prior HIV proteinase inhibitor.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
UCD Med Ctr
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Davies Med Ctr
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
Pacific Oaks Med Group
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
Novum Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Howard Univ
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
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 School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
HIV Wellness Ctr / Univ Med Ctr
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
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
Harkness Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Univ of Oklahoma Health Science / Pharmacy Practice
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
Novum Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
152063817
Country
United States
Facility Name
Respiratory Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
N Texas Ctr for AIDS & Clin Rsch
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
Thomas Street Clinic / Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981224379
Country
United States
Facility Name
San Juan Veterans Administration Med Ctr
City
San Juan
ZIP/Postal Code
009275800
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60
Results Reference
background

Learn more about this trial

A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

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