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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Calanolide A   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Pharmacokinetics Study
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

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

Estimated Enrollment:   32

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


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

Keywords provided by NIH AIDS Clinical Trials Information Service:
Anti-HIV Agents  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Calanolide A
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Anti-Retroviral Agents
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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