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A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Zidovudine
Sponsored by
Dupont Merck
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype, Reverse Transcriptase Inhibitors, efavirenz

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria Concurrent Medication: Excluded: Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]). Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir). Ketoconazole, itraconazole, and clarithromycin. Concomitant systemic therapy for acute opportunistic infection or malignancy. Excluded: Life expectancy less than 12 months. Prior Medication: Excluded: Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor. Prior antiretroviral agent within 14 days of initiating study treatment. Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication. Patients must: Have a diagnosis of HIV infection. Have CD4 counts greater than or equal to 50 cell/mm3. Have a life expectancy greater than or equal to 12 months. Be post-pubescent.

Sites / Locations

  • Phoenix Body Positive
  • Arizona Clinical Research Ctr Inc
  • Richard Stryker
  • Paul Cimoch
  • AIDS Healthcare Foundation
  • Kraus Med Group
  • Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
  • Blick Med Associates
  • Novum Inc
  • Bach and Godofsky
  • Community Research Initiative of South Florida
  • Boulevard Comprehensive Care Ctr
  • Larry Marc Bush / c/o Sally Yantis
  • Univ of Miami School of Medicine
  • Ctr for Quality Care
  • Daniel Seekins
  • Infectious Disease Research Institute
  • Treasure Coast Infectious Disease Consultants
  • Georgia Research Associates
  • Med College of Georgia
  • Infectious Diseases
  • Univ of Kentucky Med Ctr
  • Kansas City AIDS Research Consortium
  • Univ of Nebraska Med Ctr / HIV Clinic
  • Univ Med Ctr / HIV Wellness Ctr
  • Community Research Initiative on AIDS
  • Clinical Directors Network / HIV/AIDS Program Manager
  • Wake Forest Univ School of Medicine
  • Remington-Davis Inc
  • Philadelphia FIGHT
  • The Miriam Hosp
  • Research Services 2000 Inc
  • Division of Infectious Disease / Dept of Internal Medicine
  • Research Services 2000 Inc
  • Montrose Clinic
  • UT-Health Science Ctr
  • Diagnostic Clinic of San Antonio
  • Oyster Point Med Specialists
  • Novum Inc / Pharmaceutical Research Services
  • Infectious Diseases Associates
  • Javier O Morales Ramirez

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Dupont Merck
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1. Study Identification

Unique Protocol Identification Number
NCT00002410
Brief Title
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
Official Title
A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dupont Merck

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype, Reverse Transcriptase Inhibitors, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria Concurrent Medication: Excluded: Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]). Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir). Ketoconazole, itraconazole, and clarithromycin. Concomitant systemic therapy for acute opportunistic infection or malignancy. Excluded: Life expectancy less than 12 months. Prior Medication: Excluded: Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor. Prior antiretroviral agent within 14 days of initiating study treatment. Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication. Patients must: Have a diagnosis of HIV infection. Have CD4 counts greater than or equal to 50 cell/mm3. Have a life expectancy greater than or equal to 12 months. Be post-pubescent.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Clinical Research Ctr Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Richard Stryker
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Paul Cimoch
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kraus Med Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Blick Med Associates
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06901
Country
United States
Facility Name
Novum Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Boulevard Comprehensive Care Ctr
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Larry Marc Bush / c/o Sally Yantis
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33463
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ctr for Quality Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Daniel Seekins
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Infectious Disease Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Georgia Research Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Infectious Diseases
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Kentucky Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Univ of Nebraska Med Ctr / HIV Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985400
Country
United States
Facility Name
Univ Med Ctr / HIV Wellness Ctr
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Community Research Initiative on AIDS
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Clinical Directors Network / HIV/AIDS Program Manager
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Wake Forest Univ School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Remington-Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Research Services 2000 Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Division of Infectious Disease / Dept of Internal Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
752359113
Country
United States
Facility Name
Research Services 2000 Inc
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76103
Country
United States
Facility Name
Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
UT-Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Diagnostic Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Oyster Point Med Specialists
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novum Inc / Pharmaceutical Research Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Infectious Diseases Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Javier O Morales Ramirez
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

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A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

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