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

June 23, 2005 updated by: Sarawak MediChem Pharmaceuticals

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 331813405
        • South Florida Bioavailability Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • The CORE Ctr
      • Chicago, Illinois, United States, 60610
        • Chicago Ctr for Clinical Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Anderson Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15221
        • Anderson Clinical Research
    • South Carolina
      • Columbia, South Carolina, United States, 29206
        • Burnside Clinic
    • Texas
      • Galveston, Texas, United States, 775550835
        • Univ of Texas Med Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarawak MediChem Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Study Registration Dates

First Submitted

April 20, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297B
  • 57CL-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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