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Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Nelfinavir mesylate
Stavudine
Didanosine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Stavudine, RNA, Viral, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

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

Inclusion Criteria 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). Exclusion Criteria 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.

Sites / Locations

  • Sorra Research Ctr / Med Forum
  • Body Positive
  • AIDS Healthcare Foundation
  • San Francisco Gen Hosp
  • Med Alternatives
  • County Line Med CtrInc
  • Dr Gerald Pierone Jr
  • The CORE Ctr
  • Indiana Univ Med Ctr
  • Univ of Kansas School of Medicine
  • Henry Ford Hosp
  • Dartmouth-Hitchcock Med Ctr
  • NJCRI
  • Infectious Disease Assoc of Central Jersey
  • Ohio State Univ Hosp Clinic
  • Anderson Clinical Research
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Gathe, Joseph, M.D.
  • Montrose Clinic
  • Hampton Roads Med Specialists
  • Clinique Medicale du Quartier Latin
  • Clinique Medicale L'Actuele
  • Dr Roger P Leblanc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 28, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002429
Brief Title
Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
January 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.
Detailed Description
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.

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, Stavudine, RNA, Viral, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
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 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). Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Sorra Research Ctr / Med Forum
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276069
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Med Alternatives
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
County Line Med CtrInc
City
Pembrook
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Dr Gerald Pierone Jr
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Med Ctr
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
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
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dartmouth-Hitchcock Med Ctr
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
NJCRI
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Infectious Disease Assoc of Central Jersey
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Gathe, Joseph, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
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
Facility Name
Dr Roger P Leblanc
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

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