Hiv InfectionEP48 HIV CHESTNCT01207986
Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study
A study testing Low dose computed tomography (CT) in people with Hiv Infection and Lung Cancer, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography (CT) in a HIV-infected population with an… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hiv Infection, Lung Cancer
- What is being tested?
- Low dose computed tomography (CT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Aug 2014
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography (CT) in a HIV-infected population with an important smoking history. Other objectives are (1) the evaluation of the types of lung cancers in this population, as well as (2) the staging of non small cell lung cancers, (3) the description of risk factors for all lung cancers, if they are numerous enough, and (4) the number of complications of diagnosis procedures during the study.
Read the detailed description
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.
- Conditions
- Hiv Infection, Lung Cancer
- Being tested
- Low dose computed tomography (CT)
- Medical subject headings
- HIV Infections, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose computed tomography (CT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| CT screening | Other | CT interpretations and lung biopsies are guided by a suggested workup algorithm, which is not imposed in each HIV-caring centre Receives: Radiation: Low dose computed tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of lung cancers detected by lowdose computed tomography
Measured: Month 0
Secondary outcomes (4)
the types of lung cancers in this population,
Measured: Month 1 Month 3 Month 12 Month 24 Month 26
the staging of non small cell lung cancers,
Measured: Month 1 Month 3 Month 12 Month 24 Month 26
description of risk factors for all lung cancers,
Measured: Month 1 Month 3 Month 12 Month 24 Month 26
number of complications of diagnosis procedures during study
Measured: Month 1 Month 3 Month 12 Month 24 Month 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hiv InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alain Makinson, Principal investigator, University Hospital, MontpellierAntoine Cheret, Principal investigator, CHU TourcoingSophie Abgrall, Principal investigator, Hospital AvicennePierre Delamonicca, Principal investigator, Centre Hospitalier Universitaire de NicePierre Tattevin, Principal investigator, PontchaillouIsabelle Poizot Martin, Principal investigator, St Marguerite MarseilleFrancois Raffi, Principal investigator, Hotel Dieu NantesClaudine Duvivier, Principal investigator, Necker Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207986
- Sponsor's protocol ID
- AO 781-38
- Acronym
- EP48 HIV CHEST
- Status last verified
- Jul 2015
- First submitted
- 16 Sep 2010
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Makinson A, Eymard-Duvernay S, Raffi F, Abgrall S, Bommart S, Zucman D, Valour F, Cheret A, Poizot-Martin I, Duvivier C, Mauboussin JM, Bonnet F, Tattevin P, Reynes J, Le Moing V; ANRS EP48 HIV CHEST study Team. Feasibility and efficacy of early lung cancer diagnosis with chest computed tomography in HIV-infected smokers. AIDS. 2016 Feb 20;30(4):573-82. doi: 10.1097/QAD.0000000000000943.
PubMed 26829006
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study
- ClinicalTrials.gov ID
- NCT01207986
- Acronym / sponsor ID
- EP48 HIV CHEST / AO 781-38
- Conditions
- Hiv Infection, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Sep 2010 (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.
Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this study is to evaluate the prevalence of lung cancers detected by low-dose computed tomography (CT) in a HIV-infected population with an important smoking history. Other objectives are (1) the evaluation of the types of lung cancers in this population, as well as (2) the staging of non small cell lung cancers, (3) the description of risk factors for all lung cancers, if they are numerous enough, and (4) the number of complications of diagnosis procedures during the study.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT screening | Other | Radiation: Low dose computed tomography (CT)CT interpretations and lung biopsies are guided by a suggested workup algorithm, which is not imposed in each HIV-caring centre |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 40 years
- able to give written consent
- HIV positive serology
- Covered by French Social Security
- Nadir L TCD4 < 350/µl
Key exclusion criteria (7 listed)
- patients who suffered from comorbidity
- unaffiliated to the social healthy security french system
- Presence of an evolutionary cancer
- any evolutionary pathology classifying AIDS
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose computed tomography (CT) | Radiation | CT screening |
Primary outcome
the prevalence of lung cancers detected by lowdose computed tomography
Time frame: Month 0
4 secondary outcomes
the types of lung cancers in this population,
Time frame: Month 1 Month 3 Month 12 Month 24 Month 26
the staging of non small cell lung cancers,
Time frame: Month 1 Month 3 Month 12 Month 24 Month 26
description of risk factors for all lung cancers,
Time frame: Month 1 Month 3 Month 12 Month 24 Month 26
number of complications of diagnosis procedures during study
Time frame: Month 1 Month 3 Month 12 Month 24 Month 26
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 23 Apr 2026.
- Results publication: PubMed 26829006Makinson A, Eymard-Duvernay S, Raffi F, Abgrall S, Bommart S, Zucman D, Valour F, Cheret A, Poizot-Martin I, Duvivier C, Mauboussin JM, Bonnet F, Tattevin P, Reynes J, Le Moing V; ANRS EP48 HIV CHEST study Team. Feasibility and efficacy of early lung cancer diagnosis with chest computed tomography in HIV-infected smokers. AIDS. 2016 Feb 20;30(4):573-82. doi: 10.1097/QAD.0000000000000943.
- Related InfoLink provided by the sponsor.
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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.
Alain Makinson principal investigator
University Hospital, Montpellier
Antoine Cheret principal investigator
CHU Tourcoing
Sophie Abgrall principal investigator
Hospital Avicenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose computed tomography (CT) in people with Hiv Infection and Lung Cancer, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 7 inclusion and 7 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 23 Apr 2026. 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 France. 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?
the prevalence of lung cancers detected by lowdose computed tomography (time frame: Month 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207986, which also lists 1 linked publication.
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 23 Apr 2026.