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NCT Number: NCT01902693

Prospective HIV Chemotherapy Cohort Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention for this study

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust

Registry information

Official study title

Prospective Observational Study of HIV Positive Individuals on Suppressive HAART With Malignancy Undergoing Chemotherapy

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2013
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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