HIV PatientsNCT00831207
Beta-2 Microglobulin and Serum Cytokines x HAART
An observational study of HIV Patients, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Patients
- How many people
- 109 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2004to Dec 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 89 HIV-1-infected individuals assisted by the Tropical Diseases Sector of the Botucatu School of Medicine - UNESP and 20 normal blood donors at the Botucatu Blood Bank.
Who may be able to join
- HIV-1-infected individuals
- Over 18 years old
- Sign the "written consent form" (WCF)
Who cannot join
- Do not presenting other immunosuppression causes, such as neoplasias, transplantations
- Do not presenting treatment by immunosuppressive substances
- Do not presenting auto-immune diseases
- Not be using any type of immunostimulating substances
- Not at any time of gestation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, 18618-970
About this study
Official title: Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure
Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.
Read the detailed description
Objective: To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic, clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α, IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+ lymphocytes tests were performed.
Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic failure, genotyping.
- Conditions
- HIV Patients
- Keywords
- B-2 microglobulin, Serum cytokines, HIV-1, Resistance, HAART, Therapeutic failure, Genotyping.
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 |
|---|---|---|
| G1 | 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3. | |
| G2 | 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF). | |
| G3 | 43 HIV-1+ individuals undergoing HAART with TF. | |
| G4 | 20 normal individuals who served as controls for serum cytokines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.
Measured: At subject enrollment.
Secondary outcomes (1)
To assess the behavior of serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.
Measured: At subject enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startAug 2004
- Primary completionNov 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PatientsStudies 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
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
- Investigators
- Ricardo MB Almeida, MSc, Principal investigator, Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831207
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-19
- Status last verified
- Jan 2009
- First submitted
- 26 Dec 2008
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure
- ClinicalTrials.gov ID
- NCT00831207
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-19
- Conditions
- HIV Patients
- Keywords
- B-2 microglobulin, Serum cytokines, HIV-1, Resistance, HAART, Therapeutic failure, Genotyping.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
- Study start
- Aug 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jan 2009 (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.
Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.
Detailed description
Objective: To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic, clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α, IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+ lymphocytes tests were performed.
Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic failure, genotyping.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1 | – | –15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3. |
| G2 | – | –31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF). |
| G3 | – | –43 HIV-1+ individuals undergoing HAART with TF. |
| G4 | – | –20 normal individuals who served as controls for serum cytokines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 89 HIV-1-infected individuals assisted by the Tropical Diseases Sector of the Botucatu School of Medicine - UNESP and 20 normal blood donors at the Botucatu Blood Bank.
Key inclusion criteria (3 listed)
- HIV-1-infected individuals
- Over 18 years old
- Sign the "written consent form" (WCF)
Key exclusion criteria (5 listed)
- Do not presenting other immunosuppression causes, such as neoplasias, transplantations
- Do not presenting treatment by immunosuppressive substances
- Do not presenting auto-immune diseases
- Not be using any type of immunostimulating substances
- Not at any time of gestation
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
To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.
Time frame: At subject enrollment.
1 secondary outcome
To assess the behavior of serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.
Time frame: At subject enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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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.
Ricardo MB Almeida, MSc principal investigator
Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.
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 Patients, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 5 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: finished, as of the sponsor's last update on 28 Jan 2009. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure. (time frame: At subject enrollment.). 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 28 Jan 2009; AzTrials last refreshed its copy on 6 Nov 2026.