HIV InfectionsNCT00546689
Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS
An observational study of HIV Infections, run by UPECLIN HC FM Botucatu Unesp.
Trial summary
Correlation between intestinal parasites and serum level of eosinophils and IgE in individuals with HIV or aids attended at clinical hospital of the Botucatu Medical School-UNESP Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Aug 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: primary care clinic
Who may be able to join
- HIV or AIDS
- age same or superior to 18 years,
- both sexes
- assisted by the Hospital of the Clinics of Botucatu Medical School-UNESP
Who cannot join
- use of anthelminthic in the period of 30 days antecedents the it dates from collection
- individuals that don't have all of the necessary evaluations to the objectives of the study
- individuals that abandon the attendance, or that you/they are to death during the study
About this study
Official title: Phase 1 Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS
Correlation between intestinal parasites and serum level of eosinophils and IgE in individuals with HIV or aids attended at clinical hospital of the Botucatu Medical School-UNESP
Read the detailed description
The present study correlates intestinal parasitism and levels of eosonophils and of serum IgEs in patients attended at the C.H. of the School of Medicine - Botucatu/UNESP. Thirty adult patients with AIDS were analyzed in the use of HAART, aged 42 ±11 years, 14 (46.7%) male, excluding those that had used anthelminthics 30 days prior to collection. Socioeconomic questionaires were applied and 3 samples of feces were taken for parasitological exams (TF-test® method) and 5 ml of blood for counting eosinophils (automated hematological counter, Pentra 80, ABX) and IgE doses (equipment BN-100, Dade-Behring). The index of parasites was 10%, with E.nana (3.3%), E.coli (3.3%) and B.hominis (3.3%). Parasitized individuals were from an urban region with complete basic sanitation and good socioeconomic level. Normal eosinphil values were found in all samples and increased IgE values in 1 (33.3%) sample. The index of parasites was low due to good socioeconomic level and disease control. Augmented IgE levels corroborate the literature, which reports an increase characteristic of immune response in the face of parasitic infections in individuals with HIV or AIDS. In conclusion, new studies should be undertaken to evaluate the level of eosinophils associated with cytokines to obtain a better understanding of this correlation.
- Conditions
- HIV Infections
- Keywords
- HIV, aids, intestinal parasites, eosinophils, immunoglobulins, HIV/aids, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Intestinal Diseases, Parasitic
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 , 2 | those with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
all
Measured: one year
Secondary outcomes (1)
all
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startMar 2007
- Study completionAug 2007
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Paulo C Pereira, Phd, Study chair, Botucatu Medical School - UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546689
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-02
- Other IDs
- Botucatu Medical School UNESP
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2007
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS
- ClinicalTrials.gov ID
- NCT00546689
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-02
- Conditions
- HIV Infections
- Keywords
- HIV, aids, intestinal parasites, eosinophils, immunoglobulins, HIV/aids, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 19 Oct 2007 (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.
Correlation between intestinal parasites and serum level of eosinophils and IgE in individuals with HIV or aids attended at clinical hospital of the Botucatu Medical School-UNESP
Detailed description
The present study correlates intestinal parasitism and levels of eosonophils and of serum IgEs in patients attended at the C.H. of the School of Medicine - Botucatu/UNESP. Thirty adult patients with AIDS were analyzed in the use of HAART, aged 42 ±11 years, 14 (46.7%) male, excluding those that had used anthelminthics 30 days prior to collection. Socioeconomic questionaires were applied and 3 samples of feces were taken for parasitological exams (TF-test® method) and 5 ml of blood for counting eosinophils (automated hematological counter, Pentra 80, ABX) and IgE doses (equipment BN-100, Dade-Behring). The index of parasites was 10%, with E.nana (3.3%), E.coli (3.3%) and B.hominis (3.3%). Parasitized individuals were from an urban region with complete basic sanitation and good socioeconomic level. Normal eosinphil values were found in all samples and increased IgE values in 1 (33.3%) sample. The index of parasites was low due to good socioeconomic level and disease control. Augmented IgE levels corroborate the literature, which reports an increase characteristic of immune response in the face of parasitic infections in individuals with HIV or AIDS. In conclusion, new studies should be undertaken to evaluate the level of eosinophils associated with cytokines to obtain a better understanding of this correlation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 , 2 | – | –those with HIV |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- HIV or AIDS
- age same or superior to 18 years,
- both sexes
- assisted by the Hospital of the Clinics of Botucatu Medical School-UNESP
Key exclusion criteria (3 listed)
- use of anthelminthic in the period of 30 days antecedents the it dates from collection
- individuals that don't have all of the necessary evaluations to the objectives of the study
- individuals that abandon the attendance, or that you/they are to death during the study
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
all
Time frame: one year
1 secondary outcome
all
Time frame: one year
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 18 Apr 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.
Paulo C Pereira, Phd study chair
Botucatu Medical School - UNESP
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by UPECLIN HC FM Botucatu Unesp.
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 3 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 18 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
all (time frame: one year). 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 18 Apr 2008.