Prospective HIV Chemotherapy Cohort Study

October 10, 2023 updated by: Imperial College London

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Chelsea And Westminster Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proviral DNA
Time Frame: 12 weeks postcompletion of chemotherapy
Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy
12 weeks postcompletion of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy
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
Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy
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)
Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy
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
Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy
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
Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Sarah Fidler, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimated)

July 18, 2013

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRO2009
  • CHERUB 003-301 (Other Grant/Funding Number: Imperial Biomedical Research Centre award)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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