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.
2 other identifiers
interventional
80
1 country
8
Brief Summary
The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (8)
UCSD Treatment Ctr
San Diego, California, 921036329, United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, 065102483, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111, United States
NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
New York, New York, 10016, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232, United States
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, 44106, United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372321302, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-11