Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-22 @ 11:11 AM
Study NCT ID:
NCT01902693
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2013-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective HIV Chemotherapy Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Cerebrospinal fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proviral DNA', 'timeFrame': '12 weeks postcompletion of chemotherapy', 'description': 'Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Proviral DNA', 'timeFrame': 'Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy', 'description': 'Quantification of proviral DNA (intracellular DNA/MRNA)'}, {'measure': 'Viral RNA', 'timeFrame': 'Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy', 'description': 'Quantification of HIV-1 viral RNA transcripts'}, {'measure': 'Ultra-low viral load', 'timeFrame': 'Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy', 'description': 'Quantification of HIV-1 ultra-low viral load (UL-VL)'}, {'measure': 'Immune activation levels', 'timeFrame': 'Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy', 'description': 'Quantification of immune activation levels'}, {'measure': 'Histone deacetylase inhibition', 'timeFrame': 'Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy', 'description': 'Degree of histone deacetylase inhibition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Chemotherapy', 'Cohort', 'Cancer', 'HAART', 'Malignancy'], 'conditions': ['HIV', 'Cancer']}, 'descriptionModule': {'briefSummary': "Human Immunodeficiency Virus (HIV) infection is very successfully treated with a type of therapy called Highly Active AntiRetroviral Therapy (HAART). Although HAART has made a great improvement to the health and lives of all people living with HIV, HAART cannot be stopped because it is not able to 'cure' or eliminate the HIV virus from all cells in the body - the remaining viruses are referred to as 'latent' or sleeping virus. As soon as the HAART treatment is stopped the virus comes back (wakes up). It is for this reason that stopping HAART treatment is not recommended. However, it may be that other drugs if given with HAART could have a stronger effect on the latent virus. There is some evidence from laboratory research that suggests that some of the drugs we use to treat certain types of cancer may have an effect on the latent virus. The purpose of this research study is to use new laboratory research technology to measure the amount of 'latent' virus in people who are treated with HAART who then need to use chemotherapy treatments for cancer. We will look at whether the levels of HIV virus are reduced in patients having chemotherapy by looking at the virus levels before, during and after chemotherapy treatment. We do not know very much about how HIV persists in the body despite therapy and unless new approaches are developed, removal of the HIV virus from all cells in the body will not be possible.", 'detailedDescription': "STUDY DESIGN This study will be performed at one investigational site in the UK. This is a single centre, prospective observational cohort study of HIV positive individuals on suppressive HAART with malignancy undergoing chemotherapy.\n\nELIGIBILITY Individuals receiving HAART and diagnosed with either lymphoma or Kaposi's sarcoma receiving combination chemotherapy agents, which include the vinca alkaloids and taxanes, will be eligible for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited only from Chelsea and Westminster joint HIV oncology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years and able to give written informed consent\n* Be aware of their HIV status and the diagnosis of malignancy\n* Have a plasma viral load of \\< 50 HIV-1 RNA copies/ml (on suppressive HAART) at enrolment\n* Be designated to receive cytotoxic chemotherapy including one or more of the following agents: R-CHOP, ABVD, Liposomal doxorubicin (Caelyx) or liposomal daunorubicin (Daunoxome) or Paclitaxel\n\nExclusion Criteria:\n\n* Patients not receiving HAART\n* A detectable (\\>50 HIV-1 RNA copies/ml) HIV plasma viral load at screening\n* Opportunistic infections\n* Unable or unwilling to give informed consent'}, 'identificationModule': {'nctId': 'NCT01902693', 'briefTitle': 'Prospective HIV Chemotherapy Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Prospective Observational Study of HIV Positive Individuals on Suppressive HAART With Malignancy Undergoing Chemotherapy', 'orgStudyIdInfo': {'id': 'CRO2009'}, 'secondaryIdInfos': [{'id': 'CHERUB 003-301', 'type': 'OTHER_GRANT', 'domain': 'Imperial Biomedical Research Centre award'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV & chemotherapy', 'description': 'Participants will be aged ≥ 18 years, aware of their HIV status and the diagnosis of malignancy, have a plasma viral load of \\< 50 HIV-1 RNA copies/ml (on suppressive HAART) at enrolment and be designated to receive cytotoxic chemotherapy including one or more of the following agents: R-CHOP, ABVD, Liposomal doxorubicin (Caelyx) or liposomal daunorubicin (Daunoxome) or Paclitaxel.\n\nThere is no intervention for this study. Blood samples will be taken and if available from routine care surplus cerebrospinal fluid.', 'interventionNames': ['Other: No intervention for this study']}], 'interventions': [{'name': 'No intervention for this study', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['HIV & chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Sarah Fidler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}