Prospective HIV Chemotherapy Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: September 12, 2014
Last verified: August 2014

July 16, 2013
September 12, 2014
October 2013
July 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01902693 on ClinicalTrials.gov Archive Site
  • 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
Proviral DNA, viral RNA, ultra-low viral load, 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 ]
  • Quantification of proviral DNA (intracellular DNA/MRNA)
  • Quantification of HIV-1 viral RNA transcripts
  • Quantification of HIV-1 ultra-low viral load (UL-VL)
  • Quantification of immune activation levels
  • Degree of histone deacetylase inhibition
Not Provided
Not Provided
 
Prospective HIV Chemotherapy Cohort Study
Prospective Observational Study of HIV Positive Individuals on Suppressive HAART With Malignancy Undergoing Chemotherapy

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood Cerebrospinal fluid

Non-Probability Sample

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

  • HIV
  • Cancer
Other: No intervention for this study
No intervention
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.

Intervention: Other: No intervention for this study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mark Bower 020 8237 5054 m.bower@imperial.ac.uk
United Kingdom
 
NCT01902693
CRO2009, CHERUB 003-301
No
Imperial College London
Imperial College London
Imperial College Healthcare NHS Trust
Principal Investigator: Sarah Fidler Imperial College London
Imperial College London
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP