Prospective HIV Chemotherapy Cohort Study

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902693
• Other study ID #: CRO2009
• Secondary ID: CHERUB 003-301
• Status: Completed
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Cancer
• HIV

Intervention

Other:
• No intervention for this study
No intervention

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proviral DNA	Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy	12 weeks postcompletion of chemotherapy
Secondary	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
Secondary	Viral RNA	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
Secondary	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
Secondary	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
Secondary	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