Prospective HIV Chemotherapy Cohort Study

Completed

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
HIV & chemotherapy	No intervention for this study	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.

Primary Outcome Measures

Name	Time	Method
Proviral DNA	12 weeks postcompletion of chemotherapy	Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Proviral DNA	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)
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	Quantification of immune activation levels
Viral RNA	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
Ultra-low viral load	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)
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	Degree of histone deacetylase inhibition

Locations (1): Chelsea and Westminster Hospital NHS Foundation Trust
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London, United Kingdom