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

This study is currently recruiting participants.
Verified June 2012 by St Stephens Aids Trust
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01330342
First received: April 1, 2011
Last updated: June 8, 2012
Last verified: June 2012
History of Changes

April 1, 2011
June 8, 2012
May 2011
May 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01330342 on ClinicalTrials.gov Archive Site
Development of mutations in the HIV genome that may confer resistance to future treatment for HIV. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma
Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma

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.

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.
Observational
Observational Model: Case Control
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Probability Sample

HIV seropositive individuals with and without lymphoma.
  • HIV
  • Lymphoma
Not Provided
  • HIV patients without lymphoma
    HIV-infected subjects on cART without a diagnosis of lymphoma
  • HIV patients with lymphoma
    HIV seropositive individuals with lymphoma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Marta Boffito, Dr 020 3315 6507 marta.boffito@chelwest.nhs.uk
United Kingdom
 
NCT01330342
SSAT 042
No
St Stephens Aids Trust
St Stephens Aids Trust
Not Provided
Principal Investigator: Marta Boffito, Dr St Stephen's AIDS Trust
St Stephens Aids Trust
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP