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A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Saquinavir
Lamivudine
Stavudine
Zidovudine
Zalcitabine
Didanosine
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, Antiviral Agents, Saquinavir

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV infection. Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs. No more than 2 weeks of prior treatment with a protease inhibitor. No active opportunistic infection or other serious AIDS-defining condition. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption or inadequate oral intake. Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations). Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry. Active malignancy or anticipated need for chemotherapy during the study. Anticipated need for disallowed medications during the study. Concurrent Medication: Excluded: Other protease inhibitors. Prior Medication: Excluded: More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen. More than 2 weeks of any protease inhibitor.

Sites / Locations

  • Phoenix Body Positive
  • UCLA AIDS Clinical Research Ctr / Dept of Medicine
  • AIDS Research Ctr
  • UCD Med Ctr
  • UCSD Treatment Ctr
  • Mount Zion Hosp of UCSF
  • San Francisco Veterans Adm Med Cntr
  • Univ of Colorado Health Sciences Ctr
  • Whitman Walker Clinic
  • Miami Veterans Administration Med Ctr
  • Saint Joseph's Hosp
  • AIDS Research Consortium of Atlanta
  • Cook County Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Tulane Univ / Tulane / LSU Clinical Trials Unit
  • New England Med Ctr
  • Harvard Univ / Massachusetts Gen Hosp
  • Beth Israel Med Ctr
  • St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
  • Univ of Oklahoma
  • Univ of Pennsylvania / Division of Infectious Disease
  • Univ of Texas Med Branch
  • Infectious Diseases Association of Houston
  • Southern Alberta HIV Clinic / Foot Hills Hosp
  • Saint Paul's Hosp / Canadian HIV Trials Network
  • McMaster Univ Med Ctr
  • Montreal Gen Hosp / Div of Clin Immuno and Allergy

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
NCT00002162
Brief Title
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
Official Title
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
August 1997
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 evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Detailed Description
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.

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, Antiviral Agents, Saquinavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: HIV infection. Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs. No more than 2 weeks of prior treatment with a protease inhibitor. No active opportunistic infection or other serious AIDS-defining condition. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption or inadequate oral intake. Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations). Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry. Active malignancy or anticipated need for chemotherapy during the study. Anticipated need for disallowed medications during the study. Concurrent Medication: Excluded: Other protease inhibitors. Prior Medication: Excluded: More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen. More than 2 weeks of any protease inhibitor.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
UCLA AIDS Clinical Research Ctr / Dept of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
AIDS Research Ctr
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCD Med Ctr
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036329
Country
United States
Facility Name
Mount Zion Hosp of UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco Veterans Adm Med Cntr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Saint Joseph's Hosp
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
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 / Tulane / LSU Clinical Trials Unit
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Harvard Univ / Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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
St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Univ of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
Univ of Pennsylvania / Division of Infectious Disease
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Infectious Diseases Association of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Southern Alberta HIV Clinic / Foot Hills Hosp
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Saint Paul's Hosp / Canadian HIV Trials Network
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
McMaster Univ Med Ctr
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Montreal Gen Hosp / Div of Clin Immuno and Allergy
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11364377
Citation
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Results Reference
background
PubMed Identifier
9708399
Citation
Mitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9. doi: 10.1097/00002030-199811000-00001.
Results Reference
background

Learn more about this trial

A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

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