A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients
2 other identifiers
interventional
40
1 country
8
Brief Summary
To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 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
April 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- CD4+ cell count \>= 100 /mm3.
- Plasma HIV RNA \>= 30,000 copies/ml.
You may not qualify if:
- Parent or legal guardian to sign written, informed consent for patients under the age of 18.
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
- For this study, a CD4+ cell count \<= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
- Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.
- Concurrent Medication:
- Excluded:
- Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
- Patients receiving other investigational drugs.
- Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
- Treatment with immunomodulators.
- Patients on methadone.
- Concurrent Treatment:
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (8)
Marin County Specialty Clinic
Greenbrae, California, 94904, United States
Kraus Med Partners
Los Angeles, California, 90036, United States
ViRx Inc
San Francisco, California, 94109, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
MeSH Terms
Conditions
Interventions
Condition 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: 1997-04