- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002440
A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 921036329
- UCSD Treatment Ctr
-
-
Connecticut
-
New Haven, Connecticut, United States, 065102483
- Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Kansas City AIDS Research Consortium
-
-
New York
-
New York, New York, United States, 10016
- NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28232
- Carolinas Med Ctr
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve Univ / AIDS Clinical Trials Unit
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Univ of Pittsburgh Med Ctr
-
-
Tennessee
-
Nashville, Tennessee, United States, 372321302
- Vanderbilt Univ Med Ctr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Local treatment for Kaposi's sarcoma.
- GM-CSF, G-CSF or erythropoietin.
Patients must have:
- HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
- CD4+ cell count >= 100 cells/mm3 within 14 days of study drug administration.
- HIV-1 RNA >= 5,000 copies/ml within 14 days of study drug administration.
- No active or ongoing AIDS-defining opportunistic infection or disease.
- Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Prior Medication:
Allowed:
Local treatment for Kaposi's sarcoma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
- Life-threatening infection or other serious medical condition that may compromise a patient's safety.
Concurrent Medication:
Excluded:
- Other investigational agents. NOTE:
- Those available through Treatment IND or expanded access programs are evaluated individually.
- Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
- Agents with documented anti-HIV activity in vitro.
- Foscarnet.
- Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.
- Antioxidants.
Concurrent Treatment:
Excluded:
Radiation therapy within the first 24 weeks of study.
Patients with the following prior conditions are excluded:
- History of clinically relevant pancreatitis or hepatitis within the last 6 months.
- Participation in an investigational HIV-1 vaccine trial.
Prior Medication:
Excluded:
- Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.
- Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
- HIV-1 vaccine dose within the 3 months prior to study drug administration.
- Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Antibiotics, Antitubercular
- Ritonavir
- Indinavir
- Nelfinavir
- Abacavir
- Amprenavir
- Saquinavir
Other Study ID Numbers
- 238J
- CNAA2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Indinavir sulfate
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...Withdrawn
-
Merck Sharp & Dohme LLCCompletedHIV InfectionsUnited States
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompletedHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Glaxo WellcomeCompleted