Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen
2 other identifiers
interventional
500
2 countries
23
Brief Summary
This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Jul 1999
Shorter than P25 for phase_3 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMay 4, 2011
April 1, 2011
1.5 years
November 2, 1999
April 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
- Are at least 18 years old.
- Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have had severe diarrhea within 30 days of study entry.
- Have a history of pancreatic disease or any other serious condition.
- Have hepatitis within 30 days of study entry.
- Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
- Are unable to take medications by mouth.
- Have received certain medications.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203, United States
Body Positive
Phoenix, Arizona, 85016, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
San Francisco Gen Hosp
San Francisco, California, 94115, United States
Med Alternatives
Fort Lauderdale, Florida, 33308, United States
County Line Med CtrInc
Pembrook, Florida, 33023, United States
Dr Gerald Pierone Jr
Vero Beach, Florida, 32960, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 462025250, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03756, United States
NJCRI
Newark, New Jersey, 07103, United States
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, 08876, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Gathe, Joseph, M.D.
Houston, Texas, 77004, United States
Montrose Clinic
Houston, Texas, 77006, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Dr Roger P Leblanc
Montreal, Quebec, Canada
Related Publications (1)
Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
July 1, 1999
Primary Completion
January 1, 2001
Study Completion
January 1, 2001
Last Updated
May 4, 2011
Record last verified: 2011-04