Back to resultsA Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Nelfinavir mesylate
Efavirenz
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Are at least 13 years old (consent of parent or guardian required if under 18). Have a viral load of at least 10,000 copies/ml within 30 days of study entry. Agree to use a barrier method of birth control, such as condoms, during the study. Exclusion Criteria You will not be eligible for this study if you: Have hepatitis. Have any other serious medical condition besides HIV infection. Are allergic to indinavir, nelfinavir, or efavirenz. Have ever taken NNRTIs or protease inhibitors. Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.) Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry. Are enrolled or plan to enroll in another anti-HIV drug study during this study. Are pregnant or breast-feeding. Abuse alcohol or drugs.
Sites / Locations
- Pacific Oaks Med Group
- Univ of Colorado / Health Science Ctr
- AIDS Research Consortium of Atlanta
- Brown Univ School of Medicine
- Hampton Roads Med Specialists
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002235
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Agouron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002235
Brief Title
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
Official Title
A Phase II, 48-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of a Simplified Dosing Regimen of Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor and Protease Inhibitor Naive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2000
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Agouron Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
Detailed Description
Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Efavirenz
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
Are HIV-positive.
Are at least 13 years old (consent of parent or guardian required if under 18).
Have a viral load of at least 10,000 copies/ml within 30 days of study entry.
Agree to use a barrier method of birth control, such as condoms, during the study.
Exclusion Criteria
You will not be eligible for this study if you:
Have hepatitis.
Have any other serious medical condition besides HIV infection.
Are allergic to indinavir, nelfinavir, or efavirenz.
Have ever taken NNRTIs or protease inhibitors.
Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.)
Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry.
Are enrolled or plan to enroll in another anti-HIV drug study during this study.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.
Facility Information:
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Brown Univ School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
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