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| ID | Type | Description | Link |
|---|---|---|---|
| CHERUB 003-301 | Other Grant/Funding Number | Imperial Biomedical Research Centre award |
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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention for this study | Other | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Proviral DNA | Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy | 12 weeks postcompletion of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proviral DNA | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited only from Chelsea and Westminster joint HIV oncology clinic
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Fidler | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital NHS Foundation Trust | London | SW10 9NH | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Blood Cerebrospinal fluid
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 | 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 | 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 | 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 |