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Prospective HIV Chemotherapy Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902693
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : September 9, 2015
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:
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 or disease Intervention/treatment
HIV Cancer Other: No intervention for this study

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.

Study Design
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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observational Study of HIV Positive Individuals on Suppressive HAART With Malignancy Undergoing Chemotherapy
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Proviral DNA [ Time Frame: 12 weeks postcompletion of chemotherapy ]
    Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy


Secondary Outcome Measures :
  1. 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 ]
    Quantification of proviral DNA (intracellular DNA/MRNA)

  2. 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 ]
    Quantification of HIV-1 viral RNA transcripts

  3. 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 ]
    Quantification of HIV-1 ultra-low viral load (UL-VL)

  4. 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 ]
    Quantification of immune activation levels

  5. 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 ]
    Degree of histone deacetylase inhibition


Biospecimen Retention:   Samples With DNA
Blood Cerebrospinal fluid

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902693


Locations
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United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Sarah Fidler Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01902693    
Other Study ID Numbers: CRO2009
CHERUB 003-301 ( Other Grant/Funding Number: Imperial Biomedical Research Centre award )
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: February 2015
Keywords provided by Imperial College London:
HIV
Chemotherapy
Cohort
 Cancer
HAART
Malignancy