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

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ClinicalTrials.gov Identifier: NCT01330342
Recruitment Status : Unknown
Verified June 2012 by St Stephens Aids Trust.
Recruitment status was:  Recruiting
First Posted : April 6, 2011
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust

Study Description
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Brief Summary:
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 or disease
HIV 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.


Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Official Title: Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma
Study Start Date : May 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Lymphoma
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HIV patients without lymphoma
HIV-infected subjects on cART without a diagnosis of lymphoma
HIV patients with lymphoma
HIV seropositive individuals with lymphoma


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Development of mutations in the HIV genome that may confer resistance to future treatment for HIV. [ Time Frame: 3 years ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01330342     History of Changes
Other Study ID Numbers: SSAT 042
First Posted: April 6, 2011    Key Record Dates
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