Back to resultsA 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calanolide A
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: 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 You will not be eligible for this study if you: 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.
Sites / Locations
- South Florida Bioavailability Clinic
- Treasure Coast Infectious Disease Consultants
- Cook County Hosp
- Univ of Maryland Institute of Human Virology
- Boston Med Ctr / Clinical Research Office
- Beth Israel Med Ctr
- Anderson Clinical Research / Inc
- Vanderbilt Univ Med Ctr
- Univ of Texas / Med Branch at Galveston
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002243
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Sarawak MediChem Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002243
Brief Title
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
Official Title
A Phase 1B Dose-Range Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2000
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sarawak MediChem Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to test 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.
Detailed Description
Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
32 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calanolide A
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
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
You will not be eligible for this study if you:
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.
Facility Information:
Facility Name
South Florida Bioavailability Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
331813405
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Maryland Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212011192
Country
United States
Facility Name
Boston Med Ctr / Clinical Research Office
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Anderson Clinical Research / Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Univ of Texas / Med Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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