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A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Lamivudine
Stavudine
Zidovudine
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 HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, RNA, Viral, Nelfinavir, Anti-HIV Agents, Viral Load

Eligibility Criteria

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

Inclusion Criteria Patients must have: Within 15 business days prior to randomization: CD4 cell count greater than or equal to 100 cells/mm3. HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Bilateral peripheral neuropathy. Intractable diarrhea. Proven or suspected acute hepatitis within 30 days prior to study entry. Concurrent Medication: Excluded: - Therapy for any co-existing disease that may interfere with patient ability to participate in this study. Concurrent Treatment: Excluded: Therapy for any co-existing disease that may interfere with patient ability to participate in this study. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. Prior Medication: Excluded: Therapy for any previous disease that may interfere with patient ability to participate in this study. Excluded within 14 days prior to randomization: Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy. Excluded within 3 months of the start of this study or expected need at time of enrollment: Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential. Inability to tolerate oral medication. Prior Treatment: Excluded: Therapy for any previous disease that may interfere with patient ability to participate in this study. Risk Behavior: Excluded: Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.

Sites / Locations

  • Sorra Research Ctr / Med Forum
  • Body Positive
  • Hill Top Research Inc
  • UCLA Med Ctr / CARE BH-412 CHS
  • AIDS Healthcare Foundation
  • West Los Angeles VAMC
  • Sherman Oaks Hosp Research Institute
  • Harbor UCLA Med Ctr / Research and Educational Institute
  • Yale New Haven Hosp / Nathan Smith Clinic
  • GW Med Ctr / Clinical Trials Unit
  • Med Alternatives
  • Urgent Care Ctr
  • Specialty Med Care Ctrs of South Florida Inc
  • Hillsborough County Health Dept
  • Saint Josephs Hosp
  • Northwestern Univ / Div of Infect Diseases
  • Rush Presbyterian / ST Lukes Med Ctr
  • Univ of Kansas School of Medicine / Office of Rsch
  • Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
  • Dartmouth-Hitchcock Med Ctr
  • NJCRI
  • Infectious Disease Assoc of Central Jersey
  • UCT International
  • St Luke Roosevelt Hosp
  • St Mary's Hosp (Univ of Rochester/Infectious Diseases)
  • SUNY at Stony Brook / Div of Infectious Disease
  • Nalle Clinic / Clinical Research Dept
  • Associates in Med and Mental Health
  • Stephen P Hauptman
  • Med Univ of South Carolina / Div of Infect Disease
  • Univ of Texas / Med Branch at Galveston
  • Joseph C Gathe

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 13, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002411
Brief Title
A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs
Official Title
A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
September 1999 (Actual)
Study Completion Date
September 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, RNA, Viral, Nelfinavir, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Within 15 business days prior to randomization: CD4 cell count greater than or equal to 100 cells/mm3. HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Bilateral peripheral neuropathy. Intractable diarrhea. Proven or suspected acute hepatitis within 30 days prior to study entry. Concurrent Medication: Excluded: - Therapy for any co-existing disease that may interfere with patient ability to participate in this study. Concurrent Treatment: Excluded: Therapy for any co-existing disease that may interfere with patient ability to participate in this study. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. Prior Medication: Excluded: Therapy for any previous disease that may interfere with patient ability to participate in this study. Excluded within 14 days prior to randomization: Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy. Excluded within 3 months of the start of this study or expected need at time of enrollment: Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential. Inability to tolerate oral medication. Prior Treatment: Excluded: Therapy for any previous disease that may interfere with patient ability to participate in this study. Risk Behavior: Excluded: Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
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
Hill Top Research Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
UCLA Med Ctr / CARE BH-412 CHS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276069
Country
United States
Facility Name
West Los Angeles VAMC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Sherman Oaks Hosp Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Harbor UCLA Med Ctr / Research and Educational Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale New Haven Hosp / Nathan Smith Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
GW Med Ctr / Clinical Trials Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Med Alternatives
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Urgent Care Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Specialty Med Care Ctrs of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Saint Josephs Hosp
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Northwestern Univ / Div of Infect Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian / ST Lukes Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine / Office of Rsch
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
405360226
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
UCT International
City
Farmingdale
State/Province
New York
ZIP/Postal Code
11735
Country
United States
Facility Name
St Luke Roosevelt Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY at Stony Brook / Div of Infectious Disease
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Nalle Clinic / Clinical Research Dept
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Stephen P Hauptman
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Med Univ of South Carolina / Div of Infect Disease
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Univ of Texas / Med Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Joseph C Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

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