NCT00005120

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2000

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2001

First QC Date

April 20, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

CD4 Lymphocyte CountBiological MarkersAnti-HIV AgentsViral LoadPharmacokineticscalanolide A

Interventions

Calanolide ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

South Florida Bioavailability Clinic

Miami, Florida, 331813405, United States

Location

Chicago Ctr for Clinical Research

Chicago, Illinois, 60610, United States

Location

The CORE Ctr

Chicago, Illinois, 60612, United States

Location

Anderson Clinical Research

Philadelphia, Pennsylvania, 19107, United States

Location

Anderson Clinical Research

Pittsburgh, Pennsylvania, 15221, United States

Location

Burnside Clinic

Columbia, South Carolina, 29206, United States

Location

Univ of Texas Med Branch

Galveston, Texas, 775550835, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

calanolide A

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 20, 2000

First Posted

August 31, 2001

Study Start

April 1, 2000

Last Updated

June 24, 2005

Record last verified: 2001-06

Locations

US(7)