Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00005120
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075959', 'term': 'calanolide A'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-06', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-04-20', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['CD4 Lymphocyte Count', 'Biological Markers', 'Anti-HIV Agents', 'Viral Load', 'Pharmacokinetics', 'calanolide A'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are at least 18 years old.\n* Agree to use effective methods of birth control during the study.\n* Have a CD4 cell count of 200 cells/mm3 or more.\n* Have HIV levels of 5000 copies/ml or more.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have abnormal blood tests.\n* Have had a reaction to study medication.\n* Have a history of opportunistic (AIDS-related) infection or cancer.\n* Are being treated for active pulmonary tuberculosis.\n* Have a fever of 39 degrees C or more within 14 days of beginning study treatment.\n* Are unable to take medications by mouth.\n* Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment.\n* Have hepatitis, hemophilia, or other blood disorder.\n* Have significant heart, stomach, intestinal, liver, nerve, or kidney problems.\n* Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder.\n* Have taken anti-HIV drugs in the past.\n* Are taking certain medications.\n* Have had a blood transfusion within the 3 months prior to entering the study.\n* Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study.\n* Are pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT00005120', 'briefTitle': 'The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '297B'}, 'secondaryIdInfos': [{'id': '57CL-0001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Calanolide A', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '331813405', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Bioavailability Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Ctr for Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The CORE Ctr', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Anderson Clinical Research', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15221', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Anderson Clinical Research', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29206', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Burnside Clinic', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '775550835', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarawak MediChem Pharmaceuticals', 'class': 'INDUSTRY'}}}}