Prospective HIV Chemotherapy Cohort Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Imperial College London
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01902693
First received: July 16, 2013
Last updated: July 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
HIV
Cancer
Other: No intervention for this study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observational Study of HIV Positive Individuals on Suppressive HAART With Malignancy Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Proviral DNA [ Time Frame: 12 weeks postcompletion of chemotherapy ] [ Designated as safety issue: No ]
    Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy


Secondary Outcome Measures:
  • Proviral DNA [ Time Frame: Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy ] [ Designated as safety issue: No ]
    Quantification of proviral DNA (intracellular DNA/MRNA)

  • Viral RNA [ Time Frame: Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy ] [ Designated as safety issue: No ]
    Quantification of HIV-1 viral RNA transcripts

  • Ultra-low viral load [ Time Frame: Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy ] [ Designated as safety issue: No ]
    Quantification of HIV-1 ultra-low viral load (UL-VL)

  • Immune activation levels [ Time Frame: Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy ] [ Designated as safety issue: No ]
    Quantification of immune activation levels

  • Histone deacetylase inhibition [ Time Frame: Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy ] [ Designated as safety issue: No ]
    Degree of histone deacetylase inhibition


Biospecimen Retention:   Samples With DNA

Blood Cerebrospinal fluid


Estimated Enrollment: 25
Study Start Date: July 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV & chemotherapy

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.

There is no intervention for this study. Blood samples will be taken and if available from routine care surplus cerebrospinal fluid.

Other: No intervention for this study
No intervention

Detailed Description:

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.

ELIGIBILITY 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited only from Chelsea and Westminster joint HIV oncology clinic

Criteria

Inclusion Criteria:

  • Aged ≥ 18 years and able to give written informed consent
  • Be 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
  • 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

Exclusion Criteria:

  • Patients not receiving HAART
  • A detectable (>50 HIV-1 RNA copies/ml) HIV plasma viral load at screening
  • Opportunistic infections
  • Unable or unwilling to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902693

Contacts
Contact: Mark Bower 020 8237 5054 m.bower@imperial.ac.uk

Locations
United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW10 9NH
Principal Investigator: Mark Bower         
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
Principal Investigator: Sarah Fidler Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01902693     History of Changes
Other Study ID Numbers: CRO2009, CHERUB 003-301
Study First Received: July 16, 2013
Last Updated: July 18, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
HIV
Chemotherapy
Cohort
Cancer
HAART
Malignancy

ClinicalTrials.gov processed this record on September 11, 2014