Prospective HIV Chemotherapy Cohort Study

NCT01902693 | Completed

• 2 other identifiers: CRO2009CHERUB 003-301
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Cancer

Keywords

HIV; Chemotherapy; Cohort; Cancer; HAART; Malignancy

Outcome Measures

Primary Outcomes (1)

• Proviral DNA

  Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy

  12 weeks postcompletion of chemotherapy

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

  Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy

Study Arms (1)

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

Interventions

No intervention for this study OTHER

No intervention

HIV & chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Cerebrospinal fluid

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sarah Fidler

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 18, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

GB (1)