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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2001 by NIH AIDS Clinical Trials Information Service. Recruitment status was Active, not recruiting

First Received on April 20, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	Sarawak MediChem Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005120

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Calanolide A	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Calanolide A

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	16
Study Start Date:	April 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005120

Locations

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

Sponsors and Collaborators

Sarawak MediChem Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00005120 History of Changes
Other Study ID Numbers:	297B, 57CL-0001
Study First Received:	April 20, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

CD4 Lymphocyte Count
Biological Markers
Anti-HIV Agents

Viral Load
Pharmacokinetics
calanolide A

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Calanolide A
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012