HIV InfectionsNCT00001110
Effect of Anti-HIV Therapy (HAART) on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients
A study testing Bronchoalveolar lavage in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.
Trial summary
The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces lung inflammation in HIV-infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Bronchoalveolar lavage
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 1999to Apr 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have a CD4 count less than or equal to 500 cells/mm3 and an HIV RNA level greater than or equal to 5000 copies/ml.
- Are about to start a regimen of at least 3 anti-HIV drugs (HAART).
Who cannot join
- Patients will not be eligible for this study if they:
- Have ever received protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
- Have had signs or symptoms of lung disease in the past 30 days (pneumonia, bronchitis, emphysema, asthma, severe cough, or severe shortness of breath).
- Have received certain medications, including HIV vaccines.
- Have received chemotherapy within 30 days prior to study entry, or have cancer that will require chemotherapy.
- Are pregnant and will be beyond the first 3 months of pregnancy by Week 24 (Month 6) of the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects
The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces lung inflammation in HIV-infected patients.
Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is able to decrease viral load in the lungs, it should also be able to decrease lung-cell inflammation in these patients.
Read the detailed description
Lymphocytic alveolitis in HIV-infected patients probably represents a local immune response to HIV-infected cells in the lung. The intensity of lymphocytic alveolitis may therefore reflect the viral load in the lung. If so, treatment that reduces viral load in the lung (e.g., HAART) should also decrease the number of cytotoxic T lymphocytes (CTLs) in the alveolar space and should return pulmonary immune responses toward normal.
Patients are stratified by CD4 count: less than 200 cells/mm3 or 200 - 500 cells/mm3. BAL is performed and blood samples are collected prior to initiation of HAART and after 1 and 6 months of HAART. If a patient has detectable HIV in the lung after 6 months of HAART, the patient is asked to submit to an optional fourth BAL after 12 months of HAART. BAL fluid and cells are analyzed for HIV viral load, percent lymphocytes, and lymphocyte subsets. Responses in the lung are compared to simultaneous changes in these variables found in the peripheral blood. Each patient serves as his/her own control.
- Conditions
- HIV Infections
- Being tested
- Bronchoalveolar lavage
- Keywords
- Lung, HIV-1, Viremia, Anti-HIV Agents, Viral Load, Bronchoalveolar Lavage Fluid
- Medical subject headings
- HIV Infections, Viremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavageProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startAug 1999
- Study completionApr 2003
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Treatment
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- HL Twigg, Study chairJ Wheat, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001110
- Sponsor's protocol ID
- ACTG 723
- Other IDs
- AACTG 723, 10188
- Status last verified
- Jul 2013
- First submitted
- 2 Nov 1999
- Last updated
- 29 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00001110
- Acronym / sponsor ID
- ACTG 723
- Conditions
- HIV Infections
- Keywords
- Lung, HIV-1, Viremia, Anti-HIV Agents, Viral Load, Bronchoalveolar Lavage Fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 1999
- Study completion
- Apr 2003 (actual)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces lung inflammation in HIV-infected patients.
Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is able to decrease viral load in the lungs, it should also be able to decrease lung-cell inflammation in these patients.
Detailed description
Lymphocytic alveolitis in HIV-infected patients probably represents a local immune response to HIV-infected cells in the lung. The intensity of lymphocytic alveolitis may therefore reflect the viral load in the lung. If so, treatment that reduces viral load in the lung (e.g., HAART) should also decrease the number of cytotoxic T lymphocytes (CTLs) in the alveolar space and should return pulmonary immune responses toward normal.
Patients are stratified by CD4 count: less than 200 cells/mm3 or 200 - 500 cells/mm3. BAL is performed and blood samples are collected prior to initiation of HAART and after 1 and 6 months of HAART. If a patient has detectable HIV in the lung after 6 months of HAART, the patient is asked to submit to an optional fourth BAL after 12 months of HAART. BAL fluid and cells are analyzed for HIV viral load, percent lymphocytes, and lymphocyte subsets. Responses in the lung are compared to simultaneous changes in these variables found in the peripheral blood. Each patient serves as his/her own control.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive.
- Are at least 18 years old.
- Have a CD4 count less than or equal to 500 cells/mm3 and an HIV RNA level greater than or equal to 5000 copies/ml.
- Are about to start a regimen of at least 3 anti-HIV drugs (HAART).
Key exclusion criteria (6 listed)
- Have ever received protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
- Have had signs or symptoms of lung disease in the past 30 days (pneumonia, bronchitis, emphysema, asthma, severe cough, or severe shortness of breath).
- Have received certain medications, including HIV vaccines.
- Have received chemotherapy within 30 days prior to study entry, or have cancer that will require chemotherapy.
- Are pregnant and will be beyond the first 3 months of pregnancy by Week 24 (Month 6) of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar lavage | Procedure or surgery | – |
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 29 Jul 2013.
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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.
HL Twigg study chair
J Wheat study chair
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoalveolar lavage in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.
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 5 inclusion and 6 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. 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 29 Jul 2013.