Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: April 28, 2011
Last Verified: April 2011
History of Changes
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.
Drug : Lamivudine/Zidovudine
Drug : Nelfinavir mesylate
Drug : Stavudine
Drug : Didanosine
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by Bristol-Myers Squibb:
|Study Start Date:||July 1999|
|Study Completion Date:||January 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- 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.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002429
Locations Show More
|United States, Alabama|
|Sorra Research Ctr / Med Forum|
|Birmingham, Alabama, United States, 35203|
|United States, Arizona|
|Phoenix, Arizona, United States, 85016|
|United States, California|
|AIDS Healthcare Foundation|
|Los Angeles, California, United States, 900276069|
|San Francisco Gen Hosp|
|San Francisco, California, United States, 94115|
|United States, Florida|
|Fort Lauderdale, Florida, United States, 33308|
|County Line Med CtrInc|
|Pembrook, Florida, United States, 33023|
|Dr Gerald Pierone Jr|
|Vero Beach, Florida, United States, 32960|
|United States, Illinois|
|The CORE Ctr|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indiana Univ Med Ctr|
|Indianapolis, Indiana, United States, 462025250|
|United States, Kansas|
|Univ of Kansas School of Medicine|
|Wichita, Kansas, United States, 672143124|
|United States, Michigan|
|Henry Ford Hosp|
|Detroit, Michigan, United States, 48202|
|United States, New Hampshire|
|Dartmouth-Hitchcock Med Ctr|
|Lebanon, New Hampshire, United States, 03756|
|United States, New Jersey|
|Newark, New Jersey, United States, 07103|
|Infectious Disease Assoc of Central Jersey|
|Somerville, New Jersey, United States, 08876|
|United States, Ohio|
|Ohio State Univ Hosp Clinic|
|Columbus, Ohio, United States, 432101228|
|United States, Pennsylvania|
|Anderson Clinical Research|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Univ of Texas Southwestern Med Ctr of Dallas|
|Dallas, Texas, United States, 75235|
|Gathe, Joseph, M.D.|
|Houston, Texas, United States, 77004|
|Houston, Texas, United States, 77006|
|United States, Virginia|
|Hampton Roads Med Specialists|
|Hampton, Virginia, United States, 23666|
|Clinique Medicale du Quartier Latin|
|Montreal, Quebec, Canada|
|Clinique Medicale L'Actuele|
|Montreal, Quebec, Canada|
|Dr Roger P Leblanc|
|Montreal, Quebec, Canada|
Sponsors and CollaboratorsBristol-Myers Squibb
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
Additional Information:For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
|Responsible Party:||Bristol-Myers Squibb|
|ClinicalTrials.gov Identifier:||NCT00002429 History of Changes|
|Other Study ID Numbers:||039F|
|Study First Received:||November 2, 1999|
|Last Updated:||April 28, 2011|
Keywords provided by Bristol-Myers Squibb:Didanosine
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
Lamivudine, zidovudine drug combination
ClinicalTrials.gov processed this data on June 15, 2018
This information is provided by ClinicalTrials.gov.