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Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Saquinavir
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, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

16 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have an HIV count of 5,000 copies/ml or more. Have a CD4 count of 100 cells/mm3 or more. Meet specific requirements if you have ever taken NRTIs. Are 16 - 64 years old (need consent if under 18). Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks. Have taken all the available NRTIs. Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection. Have a history of weight loss, muscle pain, and loss of appetite. Have taken certain medications, including anti-HIV drugs other than those required by this study. Are pregnant or breast-feeding. Abuse alcohol or drugs. Are unable to complete the study for any reason.

Sites / Locations

  • ASC Inc
  • Dean Martin
  • Wilbert Jordan
  • Whitman Walker Clinic
  • Duval County Health Department
  • Ctr for Quality Care
  • NTouch Research Corp
  • Univ of Illinois Hosp at Chicago
  • Univ of Kentucky
  • C100 HIV Outpatient Program
  • NJ CRI
  • UMDNJ / Dept of Ob/Gyn
  • SUNY Health Sciences Ctr
  • Brookdale Univ Med Ctr
  • Mt Vernon Hosp
  • Mount Sinai Med Ctr
  • Harlem Hosp Infectious Disease
  • Mem Hosp of Rhode Island
  • Diversified Med Practices, PA
  • Univ of Virginia Health Sciences Ctr
  • Univ of British Columbia Oak Tree Clinic
  • Programe DeSIDA De San Juan

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
NCT00002229
Brief Title
Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
Official Title
A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men
Study Type
Interventional

2. Study Status

Record Verification Date
December 1999
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
The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
Detailed Description
Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.

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, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saquinavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have an HIV count of 5,000 copies/ml or more. Have a CD4 count of 100 cells/mm3 or more. Meet specific requirements if you have ever taken NRTIs. Are 16 - 64 years old (need consent if under 18). Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks. Have taken all the available NRTIs. Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection. Have a history of weight loss, muscle pain, and loss of appetite. Have taken certain medications, including anti-HIV drugs other than those required by this study. Are pregnant or breast-feeding. Abuse alcohol or drugs. Are unable to complete the study for any reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Palleja
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
C Karol
Official's Role
Study Chair
Facility Information:
Facility Name
ASC Inc
City
Hobson City
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
Facility Name
Dean Martin
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Wilbert Jordan
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Duval County Health Department
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Ctr for Quality Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
NTouch Research Corp
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Univ of Illinois Hosp at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
C100 HIV Outpatient Program
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
NJ CRI
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
UMDNJ / Dept of Ob/Gyn
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
SUNY Health Sciences Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Brookdale Univ Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Mt Vernon Hosp
City
Mt. Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
100296574
Country
United States
Facility Name
Harlem Hosp Infectious Disease
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Mem Hosp of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Diversified Med Practices, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Univ of Virginia Health Sciences Ctr
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Univ of British Columbia Oak Tree Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Programe DeSIDA De San Juan
City
San Turce
ZIP/Postal Code
00908
Country
Puerto Rico

12. IPD Sharing Statement

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Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

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