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

• Conditions: HIV; Lymphoma

• Registration Number: NCT01330342
• Lead Sponsor: St Stephens Aids Trust

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.

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 Timeline

• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2011-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of multi-drug resistance (in terms of expression of transmembrane transporters and their transcriptional regulators) in HIV-infected patients with lymphoma.	3 years

Secondary Outcome Measures

Name	Time	Method
Development of mutations in the HIV genome that may confer resistance to future treatment for HIV.	3 years

Trial Locations

Locations (1)

St Stephen's Centre; 🇬🇧 London, United Kingdom