To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RTNCT01546376
Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients
An observational study of To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT and To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT and last weeks of RT . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT, To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT
- What is being tested?
- Radiation therapy and Venepuncture
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2009to not given
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV positive cancer patients Curative RT treatment
Who may be able to join
- Age 18-65 years
- HIV positive cancer patients
- Photon beam RT, conventional fraction >= 4000 cgy in 4 weeks
Who cannot join
- CD4 count < 200 cell/ml and not received anti retro viral
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rajavithi Hospital
Bangkok, Bangkok, 10400
Pathomphorn Siraprapasiri, MD, 66-89-6662960, spathomphorn@gmail.com
About this study
Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT and last weeks of RT .
- Conditions
- To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT, To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT
- Being tested
- Radiation therapy, Venepuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
External photon beam radiation therapy dosage 4000-7000 CGy
VenepunctureOther
Venepuncture for CD4 and viral load count at Week 0, Last week of Radiation, and 12, 24 Week follow up
| Study group | Role | What they receive |
|---|---|---|
| HIV-cancer patients who recived RT | Not described Receives: Radiation: Radiation therapy; Other: Venepuncture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RTStudies 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546376
- Sponsor's protocol ID
- THAIHIV001
- Status last verified
- Jan 2009
- First submitted
- 2 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients
- ClinicalTrials.gov ID
- NCT01546376
- Acronym / sponsor ID
- THAIHIV001
- Conditions
- To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT, To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- Aug 2009
- First posted
- 7 Mar 2012 (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.
Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT and last weeks of RT .
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-cancer patients who recived RT | – | Radiation: Radiation therapy, Other: Venepuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive cancer patients Curative RT treatment
Key inclusion criteria (3 listed)
- Age 18-65 years
- HIV positive cancer patients
- Photon beam RT, conventional fraction >= 4000 cgy in 4 weeks
Key exclusion criteria (1 listed)
- CD4 count < 200 cell/ml and not received anti retro viral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyExternal photon beam radiation therapy dosage 4000-7000 CGy | Radiation | HIV-cancer patients who recived RT |
| VenepunctureVenepuncture for CD4 and viral load count at Week 0, Last week of Radiation, and 12, 24 Week follow up | Other | HIV-cancer patients who recived RT |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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.
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 To Study Immunostatus of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT and To Study HIV Viral Load of HIV-cancer Patients Who Recived RT Befor RT and Last Week of RT, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 3 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 7 Mar 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 Thailand. 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 Pathomphorn Siraprapasiri, MD (66-89-6662960, spathomphorm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Mar 2012.