A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment
NCT ID: NCT00002243
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
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Calanolide A
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a CD4 count of at least 250 cells/mm3.
* Have an HIV count (viral load) of at least 5,000 copies/ml.
* Are at least 18 years old.
Exclusion Criteria
* Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study.
* Have ever received anti-HIV medications.
* Test positive for hepatitis B.
* Have received a blood (or red blood cell) transfusion within 3 months prior to study entry.
* Have severe diarrhea.
* Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease.
* Have hemophilia or another blood disorder.
* Have received certain medications or vaccines within 30 days prior to study entry.
* Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.
18 Years
ALL
No
Sponsors
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Sarawak MediChem Pharmaceuticals
INDUSTRY
Locations
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South Florida Bioavailability Clinic
Miami, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, United States
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, United States
Beth Israel Med Ctr
New York, New York, United States
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Univ of Texas / Med Branch at Galveston
Galveston, Texas, United States
Countries
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Other Identifiers
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57CL-9802
Identifier Type: -
Identifier Source: secondary_id
297A
Identifier Type: -
Identifier Source: org_study_id