Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors
NCT ID: NCT00002361
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
30 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indinavir sulfate
Ritonavir
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry.
* Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry.
* Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly).
* Experienced treatment failure within 24 weeks of study entry.
* Are 18 years of age or older.
* Agree to use effective barrier methods of birth control (such as condoms) during the study.
Exclusion Criteria
* Are allergic to ritonavir or indinavir.
* Have hepatitis.
* Have an abnormal chest x-ray or abnormal liver function tests.
* Have taken 2 protease inhibitors at the same time for 7 or more days.
* Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry.
* Have a medical condition that might make it unsafe for you to take the study drugs.
* Have experienced resistance to NRTIs and no new NRTI therapy is possible.
* Have taken certain medications.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Northwestern Univ / Div of Infect Diseases
Chicago, Illinois, United States
Chase Braxton Health Service
Baltimore, Maryland, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Albany Med College
Albany, New York, United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, United States
The Research and Education Group
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
088-00
Identifier Type: -
Identifier Source: secondary_id
246S
Identifier Type: -
Identifier Source: org_study_id