A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks
Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- HIV positive
- No active heart disease
Exclusion Criteria:
- Pregnant or breast feeding
- Unwilling to use birth control or abstinence to prevent pregnancy
- Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
- Plan to receive NNRTIs while in the study
- Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
- Alcohol or substance abuse
- Hepatitis
Sites / Locations
Outcomes
Primary Outcome Measures
Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Secondary Outcome Measures
CD4 cell counts will be measured at predetermined time points to determine change from baseline
Full Information
NCT ID
NCT00541463
First Posted
October 9, 2007
Last Updated
February 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00541463
Brief Title
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
Official Title
A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks
Primary Outcome Measure Information:
Title
Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Secondary Outcome Measure Information:
Title
CD4 cell counts will be measured at predetermined time points to determine change from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
HIV positive
No active heart disease
Exclusion Criteria:
Pregnant or breast feeding
Unwilling to use birth control or abstinence to prevent pregnancy
Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
Plan to receive NNRTIs while in the study
Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
Alcohol or substance abuse
Hepatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
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