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A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Dose-Response Relationship, Drug, HIV Protease Inhibitors, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors

Eligibility Criteria

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

Inclusion Criteria Patients must have: Documented HIV-1 seropositive status. CD4 count greater than 100 cells/mm3. Parental consent for patients under 18.

Sites / Locations

  • 1917 Research Clinic
  • Kaiser Permanente / Infectious Disease
  • Tower ID Med Associates
  • Ctr for AIDS Research / Education and Service (CARES)
  • San Francisco Gen Hosp / UCSF AIDS Program
  • HIV Clinical Research
  • Univ of Miami School of Medicine
  • AIDS Research Consortium of Atlanta
  • Ponce de Leon Ctr
  • Northwestern Univ Med School
  • Rush Presbyterian St Lukes Med Ctr
  • Natl Naval Med Ctr / Special Immunology Clinic
  • Brigham and Women's Hosp
  • Boston Med Ctr / Clinical Research Office
  • Univ Health Ctr 7D
  • Kansas City Free Health Clinic
  • Education & Research Building
  • Garden State Infectious Diseases / E I P Kennedy Health Sys
  • Albany Med College / Div of HIV Medicine
  • SUNY / Health Science Ctr at Brooklyn
  • New York Hosp of Queens / AIDS Ctr
  • CRIA
  • St Vincents Hosp and Med Ctr / Div of HIV Med
  • Anderson Clinical Research
  • Akron City Hospital
  • Thomas Jefferson Univ
  • Anderson Clinical Research
  • Houston Clinical Research Network / Southhampton Med Group
  • Univ of Utah School Of Medicine / Div of Infec Disease

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00002406
Brief Title
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
Official Title
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 1999
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
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
Detailed Description
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms: Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Dose-Response Relationship, Drug, HIV Protease Inhibitors, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Documented HIV-1 seropositive status. CD4 count greater than 100 cells/mm3. Parental consent for patients under 18.
Facility Information:
Facility Name
1917 Research Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Kaiser Permanente / Infectious Disease
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ctr for AIDS Research / Education and Service (CARES)
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
San Francisco Gen Hosp / UCSF AIDS Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
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
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Ponce de Leon Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Univ Med School
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
Natl Naval Med Ctr / Special Immunology Clinic
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Med Ctr / Clinical Research Office
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Univ Health Ctr 7D
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Kansas City Free Health Clinic
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Education & Research Building
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Garden State Infectious Diseases / E I P Kennedy Health Sys
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albany Med College / Div of HIV Medicine
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
SUNY / Health Science Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York Hosp of Queens / AIDS Ctr
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
CRIA
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
St Vincents Hosp and Med Ctr / Div of HIV Med
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Anderson Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Thomas Jefferson Univ
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Houston Clinical Research Network / Southhampton Med Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Univ of Utah School Of Medicine / Div of Infec Disease
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

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