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Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study

40 Years
85 Years
Open (Enrolling)
Hiv Infection, Lung Cancer

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Trial Information

Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study

Background Epidemiological studies in France and in the western world have shown that lung
cancers are the first cause of mortality amongst the non-AIDS classifying cancers in
HIV-infected individuals, despite the introduction of combination antiretroviral therapies.
Compared to the general population, there is an increased risk of lung cancer in
HIV-infected individuals, even after adjustment on smoking and age, estimated to be around
2.6 compared to the general population. Outcomes are dismal, as diagnoses in HIV-infected
individuals are usually made at very advanced stages (usually stage III or IV) without
screening. Two non-randomized studies of CT-screening in a non HIV-infected population
exposed to smoking have shown an important rate of early lung cancer detection and a high
level of survival at 5 or 10 years. Despite a probable high prevalence of lung cancer in the
HIV-infected population, no lung cancer screening or early diagnosis studies have been
realised, and the prevalence is yet to be determined. We deduced from different studies of
non HIV-infected populations a 3% prevalence in the HIV-infected population.

Methods Prospective multicentric and national study evaluating the prevalence of lung
cancers through low-dose CT of 450 individuals with a known HIV-infection, with a nadir
level of TCD4 cells < 350/µl, ≥ 40 years old and with a smoking history ≥ 20 packs a year
(either active or with <3 years of weaning). CT interpretations and lung biopsies are guided
by a suggested workup algorithm, which is not imposed in each HIV-caring centre.

Inclusion and follow up period Inclusion period will be 9 months, followed, in case of the
discovery of a small nodule, by a CT follow up scheme of up to two years from first
diagnosis. The study closes after 26 months of follow up.

Awaited results For the first time, this prospective study of lung cancers will estimate the
prevalence of these cancers screened in the HIV-infected population. Risks associated with
the incidence of this cancer will be investigated, including potential immune factors. An
increased number of stage I non small cell lung cancers are expected.

Inclusion Criteria:

- Age ≥ 40 years

- able to give written consent

- HIV positive serology

- Covered by French Social Security

- Nadir L TCD4 < 350/µl

- Rate of LTCD4 > 100/µl at inclusion

- Addiction to smoking > 20 packages years, active person or deprived since < 3 years

Exclusion Criteria:

- patients who suffered from comorbidity

- unaffiliated to the social healthy security french system

- Presence of an evolutionary cancer

- any evolutionary pathology classifying AIDS

- Pregnancy

- Recent lung infection (< 2 months)

- Be under protection (saving) of justice

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

the prevalence of lung cancers detected by lowdose computed tomography

Outcome Time Frame:

Month 0

Safety Issue:


Principal Investigator

Alain Makinson

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Montpellier


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AO 781-38



Start Date:

February 2011

Completion Date:

June 2014

Related Keywords:

  • HIV Infection
  • Lung Cancer
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lung Neoplasms
  • Smoking