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

This study has been completed.

First Received on November 2, 1999. 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:	NCT00002243

Purpose

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.

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Calanolide A

U.S. FDA Resources

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

Estimated Enrollment:

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.

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002243

Locations

United States, Florida
South Florida Bioavailability Clinic
Miami, Florida, United States, 331813405
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Illinois
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Maryland
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, United States, 212011192
United States, Massachusetts
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, United States, 02118
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, Pennsylvania
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37212
United States, Texas
Univ of Texas / Med Branch at Galveston
Galveston, Texas, United States, 775550835

Sponsors and Collaborators

Sarawak MediChem Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002243 History of Changes
Other Study ID Numbers:	297A, 57CL-9802
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
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
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012