HIVSSAT042NCT01330342
Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma
An observational study of HIV and Lymphoma, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV seropositive individuals with and without lymphoma.
Who may be able to join
- 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.
Who cannot join
- Receiving anti-tuberculosis treatment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Stephen's Centre
London, SW10 9NH
Marta Boffito, Dr, marta.boffito@chelwest.nhs.uk
Marta Boffito, Dr
About this study
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.
Read the 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.
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV patients without lymphoma | HIV-infected subjects on cART without a diagnosis of lymphoma | |
| HIV patients with lymphoma | HIV seropositive individuals with lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of multi-drug resistance (in terms of expression of transmembrane transporters and their transcriptional regulators) in HIV-infected patients with lymphoma.
Measured: 3 years
Secondary outcomes (1)
Development of mutations in the HIV genome that may confer resistance to future treatment for HIV.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Dr, Principal investigator, St Stephen's AIDS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330342
- Sponsor's protocol ID
- SSAT 042
- Acronym
- SSAT042
- Status last verified
- Jun 2012
- First submitted
- 1 Apr 2011
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma
- ClinicalTrials.gov ID
- NCT01330342
- Acronym / sponsor ID
- SSAT042 / SSAT 042
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV patients without lymphoma | – | –HIV-infected subjects on cART without a diagnosis of lymphoma |
| HIV patients with lymphoma | – | –HIV seropositive individuals with lymphoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV seropositive individuals with and without lymphoma.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Receiving anti-tuberculosis treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Development of mutations in the HIV genome that may confer resistance to future treatment for HIV.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Boffito, Dr principal investigator
St Stephen's AIDS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Lymphoma, run by St Stephens Aids Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Boffito, Dr (020 3315 6507, marta.boffito@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.