HIV InfectionsNCT00746473
Assessment of Cytokine Values in Serum and by RT-PCR in HIV-1 Individuals With and Without HAART
An observational study of HIV Infections, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or… Read more about this study
- Who is it for?
- Ages 22 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 73 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2004to Oct 2005
- 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 22 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All 73 HIV-1 infected individuals were submitted to full clinical observation including associated opportunistic diseases at time of blood collection for cytokine detection.
Who may be able to join
- HIV infection
Who cannot join
- no HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cytokine Values in Serum and by Specific cDNA Amplification and Detection Using RT-PCR in HIV-1 Infected Individuals With and Without Highly Active Anti-Retroviral Therapy (HAART)
A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (>80% - r2>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups.
Read the detailed description
A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment (ARV) at the AIDS Day-Hospital, Botucatu School of Medicine, Unesp. Between August 2004 and October 2005, 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (>80% - r2>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups. Several authors have recently drawn attention to the substantial apoptosis of infected and non infected CD4+T cells, mainly during primary infection, persisting only in those with INF-g phenotype producer and not IL-2.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
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 |
|---|---|---|
| 1 | 15 HIV-1 infected individuals, with or without AIDS, who had never received ARV. These patients had not yet been indicated for ARV, or had had HIV-1 infection diagnosed a few days before inclusion in this study. | |
| 2 | 27 HIV-1 infected individuals, sick or not, on ARV treatment, five with two nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and one nonnucleoside reverse transcriptase inhibitor (NNRTI), and 22 on HAART with two NRTI, or one NRTI and one NNRTI, and one protease inhibitor (PI), and VL equal to or greater than 50 copies of plasma RNA/mL. Treatment duration in this group varied between three and 145 months (mean 53.62 months; median 42 months). | |
| 3 | 31 HIV-1 infected individuals on ARV treatment, 16 on HAART with two NRTI, or one NRTI and one NNRTI, and one PI, and 15 with two NRTI and one NNRTI. All G3 patients had undetectable VL for at least the past 6 months. Treatment in this group varied between five to 108 months (mean 48.13 months; median 42 months). | |
| 4 | 20 blood donors without clinical complaints and negative for anti-HIV-1/2 antibodies. None of them showed any sign of disease. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startAug 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Domingos A Meira, PhD, MD, Principal investigator, Faculdade de Medicina de Botucatu, Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746473
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-12
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2008
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cytokine Values in Serum and by Specific cDNA Amplification and Detection Using RT-PCR in HIV-1 Infected Individuals With and Without Highly Active Anti-Retroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00746473
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-12
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 4 Sep 2008 (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.
A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (>80% - r2>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups.
Detailed description
A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment (ARV) at the AIDS Day-Hospital, Botucatu School of Medicine, Unesp. Between August 2004 and October 2005, 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (>80% - r2>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups. Several authors have recently drawn attention to the substantial apoptosis of infected and non infected CD4+T cells, mainly during primary infection, persisting only in those with INF-g phenotype producer and not IL-2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –15 HIV-1 infected individuals, with or without AIDS, who had never received ARV. These patients had not yet been indicated for ARV, or had had HIV-1 infection diagnosed a few days before inclusion in this study. |
| 2 | – | –27 HIV-1 infected individuals, sick or not, on ARV treatment, five with two nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and one nonnucleoside reverse transcriptase inhibitor (NNRTI), and 22 on HAART with two NRTI, or one NRTI and one NNRTI, and one protease inhibitor (PI), and VL equal to or greater than 50 copies of plasma RNA/mL. Treatment duration in this group varied between three and 145 months (mean 53.62 months; median 42 months). |
| 3 | – | –31 HIV-1 infected individuals on ARV treatment, 16 on HAART with two NRTI, or one NRTI and one NNRTI, and one PI, and 15 with two NRTI and one NNRTI. All G3 patients had undetectable VL for at least the past 6 months. Treatment in this group varied between five to 108 months (mean 48.13 months; median 42 months). |
| 4 | – | –20 blood donors without clinical complaints and negative for anti-HIV-1/2 antibodies. None of them showed any sign of disease. |
Who may qualify
- Ages
- 22 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All 73 HIV-1 infected individuals were submitted to full clinical observation including associated opportunistic diseases at time of blood collection for cytokine detection.
Key inclusion criteria (1 listed)
- HIV infection
Key exclusion criteria (1 listed)
- no HIV infection
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
Not reported in the source record.
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 4 Sep 2008.
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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.
Domingos A Meira, PhD, MD principal investigator
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 Infections, 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 1 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: finished, as of the sponsor's last update on 4 Sep 2008. 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.
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 4 Sep 2008.