Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma (SSAT042)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by St Stephens Aids Trust.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
St Stephens Aids Trust
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
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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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330342
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | April 1, 2011 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016