NCT00904384

Brief Summary

The prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV infection and COPD might be of interest to both conditions. The research hypotheses of this study are: In patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB):

  1. 1.The Prevalence of airflow obstruction in patients with HIV infection is higher than in the general population.
  2. 2.In these patients, the prevalence of emphysema detected by HRCT is common (greater than or equal to 15%)
  3. 3.DLCO measurement is a good marker for the presence of emphysema on CT
  4. 4.The inflammatory response is different from that seen in patients with COPD and / or emphysema without HIV infection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

May 15, 2009

Last Update Submit

June 9, 2011

Conditions

HIV InfectionsCOPD

Keywords

HIV+COPDemphysema

Outcome Measures

Primary Outcomes (1)

  • Prevalence of airflow obstruction compatible with COPD in patients with HIV infection

    cross-sectional

Secondary Outcomes (5)

  • To determine the prevalence (and severity) of emphysema (HRCT)

    Cross-sectional

  • To Identify risk factors associated with the development of COPD and / or emphysema

    Cross-sectional

  • To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT

    Cross-sectional

  • To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms

    Cross-sectional

  • To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection

    Cross-sectional

Study Arms (2)

HIV+

Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain

Reference group

Same determinations as in HIV+ cases will be obtained in the control group of COPD patients without HIV infection as part of the study PAC-EPOC (FIS 05/2082)

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited from the HIV outpatient consultation of the Internal Medicine Department of Hospital Universitario Son Dureta (HUSD), in Mallorca, Spain. The HUSD is the tertiary, reference hospital in the CAIB.

You may qualify if:

  • HIV infection in stable phase (minimum of three months)
  • Being followed-up in external HUSD consultations (on a regular basis)
  • Age 40-69 years

You may not qualify if:

  • Chronic non-respiratory disease in terminal stage (stage IV or V of chronic kidney failure, heart failure, advanced chronic liver disease (Child C))
  • Lack of cooperation
  • Estimated survival of less than 1 year or Karnofsky \<70
  • Pregnancy
  • Opportunistic infection in the last month
  • Post lung resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsPulmonary Disease, Chronic ObstructiveEmphysema

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Melchor Riera, MD

    Hospital Universitario Son Dureta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

July 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

ES(1)