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The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calanolide A
Sponsored by
Sarawak MediChem Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring CD4 Lymphocyte Count, Biological Markers, Anti-HIV Agents, Viral Load, Pharmacokinetics, calanolide A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Agree to use effective methods of birth control during the study. Have a CD4 cell count of 200 cells/mm3 or more. Have HIV levels of 5000 copies/ml or more. Exclusion Criteria Patients will not be eligible for this study if they: Have abnormal blood tests. Have had a reaction to study medication. Have a history of opportunistic (AIDS-related) infection or cancer. Are being treated for active pulmonary tuberculosis. Have a fever of 39 degrees C or more within 14 days of beginning study treatment. Are unable to take medications by mouth. Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment. Have hepatitis, hemophilia, or other blood disorder. Have significant heart, stomach, intestinal, liver, nerve, or kidney problems. Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder. Have taken anti-HIV drugs in the past. Are taking certain medications. Have had a blood transfusion within the 3 months prior to entering the study. Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study. Are pregnant or breast-feeding.

Sites / Locations

  • South Florida Bioavailability Clinic
  • Chicago Ctr for Clinical Research
  • The CORE Ctr
  • Anderson Clinical Research
  • Anderson Clinical Research
  • Burnside Clinic
  • Univ of Texas Med Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 20, 2000
Last Updated
June 23, 2005
Sponsor
Sarawak MediChem Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00005120
Brief Title
The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title
A Phase IB 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
June 2001
Overall Recruitment Status
Unknown status
Study Start Date
April 2000 (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 see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
Detailed Description
Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
CD4 Lymphocyte Count, Biological Markers, Anti-HIV Agents, Viral Load, Pharmacokinetics, calanolide A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
16 (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 Patients may be eligible for this study if they: Are at least 18 years old. Agree to use effective methods of birth control during the study. Have a CD4 cell count of 200 cells/mm3 or more. Have HIV levels of 5000 copies/ml or more. Exclusion Criteria Patients will not be eligible for this study if they: Have abnormal blood tests. Have had a reaction to study medication. Have a history of opportunistic (AIDS-related) infection or cancer. Are being treated for active pulmonary tuberculosis. Have a fever of 39 degrees C or more within 14 days of beginning study treatment. Are unable to take medications by mouth. Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment. Have hepatitis, hemophilia, or other blood disorder. Have significant heart, stomach, intestinal, liver, nerve, or kidney problems. Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder. Have taken anti-HIV drugs in the past. Are taking certain medications. Have had a blood transfusion within the 3 months prior to entering the study. Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study. Are pregnant or breast-feeding.
Facility Information:
Facility Name
South Florida Bioavailability Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
331813405
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Anderson Clinical Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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