Back to resultsComparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nelfinavir mesylate
Stavudine
Didanosine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Are at least 18 years old. Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3. Exclusion Criteria You will not be eligible for this study if you: Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.) Have severe diarrhea. Are pregnant or breast-feeding. Have a history of pancreatic disease or any other serious condition. Have hepatitis within 30 days prior to study entry. Cannot take medications by mouth. Have received certain medications.
Sites / Locations
- Sorra Research Ctr / Med Forum
- AIDS Healthcare Foundation
- Robert Scott MD
- Beacon Clinic / Boulder Community Hosp
- Community Health Care
- Immunity Care and Research Inc
- HIV Clinical Research Ctr
- South Shore Hosp
- Saint Josephs Comprehensive Research Institute
- AIDS Research Consortium of Atlanta
- Chicago Ctr for Clinical Research
- Univ of Kansas School of Medicine
- Univ of Nebraska Med Ctr
- Clinical Studies of Las Vegas
- Anderson Clinical Research Inc
- Anderson Clinical Research Inc
- Coastal Carolina Research Ctr
- Oak Lawn Physicians Group
- Univ of Texas Southwestern Med Ctr of Dallas
- Nicholaos Bellos
- Houston Clinical Research Network / Div of Montrose Clinic
- Swedish Med Ctr
- Clinique Medicale du Quartier Latin
- Clinique Medicale L'Actuele
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002224
Brief Title
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
Official Title
Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
March 1999 (Actual)
Study Completion Date
March 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).
Detailed Description
Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
Are HIV-positive.
Are at least 18 years old.
Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.
Exclusion Criteria
You will not be eligible for this study if you:
Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)
Have severe diarrhea.
Are pregnant or breast-feeding.
Have a history of pancreatic disease or any other serious condition.
Have hepatitis within 30 days prior to study entry.
Cannot take medications by mouth.
Have received certain medications.
Facility Information:
Facility Name
Sorra Research Ctr / Med Forum
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276069
Country
United States
Facility Name
Robert Scott MD
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Beacon Clinic / Boulder Community Hosp
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Community Health Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Immunity Care and Research Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
HIV Clinical Research Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
South Shore Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Saint Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
303081962
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
672143124
Country
United States
Facility Name
Univ of Nebraska Med Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985400
Country
United States
Facility Name
Clinical Studies of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Anderson Clinical Research Inc
City
Rego Park
State/Province
New York
ZIP/Postal Code
11374
Country
United States
Facility Name
Anderson Clinical Research Inc
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19604
Country
United States
Facility Name
Coastal Carolina Research Ctr
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Oak Lawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
752359103
Country
United States
Facility Name
Nicholaos Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Clinical Research Network / Div of Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Swedish Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
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