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Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma (SSAT042)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by St Stephens Aids Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330342
First Posted: April 6, 2011
Last Update Posted: June 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St Stephens Aids Trust
  Purpose
The study's chief objective is to observe the evolution of cellular (in terms of expression of transmembrane transporters and their transcriptional regulators) and viral resistance (in terms of development of mutations in the HIV genome that may confer resistance to future treatment for HIV) in HIV-infected patients with lymphoma.

Condition
HIV Lymphoma

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma

Resource links provided by NLM:


Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • Development of multi-drug resistance (in terms of expression of transmembrane transporters and their transcriptional regulators) in HIV-infected patients with lymphoma. [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Development of mutations in the HIV genome that may confer resistance to future treatment for HIV. [ Time Frame: 3 years ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV patients without lymphoma
HIV-infected subjects on cART without a diagnosis of lymphoma
HIV patients with lymphoma
HIV seropositive individuals with lymphoma

Detailed Description:

The study team will take two or three tubes of blood on three occasions during the course of chemotherapy. The total amount of blood required for this research project is 64mL (approximately 4 tablespoons).

This will allow better understanding of the changes that take place in the blood and the HIV virus itself. It is hoped that this will provide new insights that may aid the understanding and treatment of HIV patients with lymphoma.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV seropositive individuals with and without lymphoma.
Criteria

Inclusion Criteria:

  • The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
  • Documented HIV-1 infection.
  • Diagnosis of lymphoma (with the exclusion of the five subjects that will be controls).
  • On cART or about to start cART as part of clinical routine care before the initiation of chemotherapy.

Exclusion Criteria:

- Receiving anti-tuberculosis treatment.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330342


Contacts
Contact: Marta Boffito, Dr 020 3315 6507 marta.boffito@chelwest.nhs.uk

Locations
United Kingdom
St Stephen's Centre Recruiting
London, United Kingdom, SW10 9NH
Contact: Marta Boffito, Dr       marta.boffito@chelwest.nhs.uk   
Principal Investigator: Marta Boffito, Dr         
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Marta Boffito, Dr St Stephen's AIDS Trust
  More Information

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01330342     History of Changes
Other Study ID Numbers: SSAT 042
First Submitted: April 1, 2011
First Posted: April 6, 2011
Last Update Posted: June 11, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases