HIVPhase 1NCT00327080
Sildenafil to Treat HIV-Associated Pulmonary Hypertension
A Phase 1 study testing MRI, L-NMMA and Acetylcholine in people with HIV, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will examine how blood pressure in the lungs is controlled in healthy people, people with HIV and people with HIV and pulmonary artery hypertension (high blood pressure in the lungs, also called PAH). PAH sometimes develops in people with HIV, but it is not known why this occurs or how best to treat it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- MRI, L-NMMA and Acetylcholine
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2006to 18 Mar 2009
- Phase
- Phase 1
- 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
- All volunteer subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and exclusion criteria.
- For Healthy Volunteers:
- Males or females, 18 years of age or older.
- No history of HIV infection.
- EKG and echocardiogram with no evidence of clinical relevant heart disease (including TRV less than 2.5 m/s)
- No history of causes of pulmonary hypertension such as collagen vascular disease, chronic liver disease with ALT or AST greater than 2 times the upper limit of normal or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, or pulmonary parenchymal disease with hypoxemia.
Show all 21Show fewer
- No history of diseases thought to be related to development of endothelial dysfunction including systemic hypertension or diabetes requiring drug therapy, hypercholesterolemia and obesity.
- No history of anemia, thrombocytopenia or coagulopathy.
- No history of renal insufficiency.
- No medical conditions requiring chronic medication use with the exception of:
- Heartburn, GERD
- Environmental allegeries, post nasal drip or non-allergic rhinitis
- Asthma with no history of oral steroid use, weekly inhaled steroids, or hospitalization for asthma exacerbation.
- Dermatologic conditions that do not require the use of oral steroids or other immunosuppressants.
- No more than 20 cigarettes per year for the previous 2 years and no cigarette use for 30 days prior to the screening evaluation until completion of the study.
- For HIV Positive Volunteers:
- Males or females, 18 years of age or older.
- Diagnosis of HIV infection.
- Under the care of a primary care physician.
- No history of other potential causes of pulmonary hypertension such as collagen vascular disease, chronic liver disease with ALT or AST greater than 2 times the upper limit of normal or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, or pulmonary parenchymal disease with hypoxemia.
- For stage 3 enrollment: symptomatic pulmonary hypertension with MPAP greater than or equal to 25 mmHg and six-minute walk distance between 150-450 m.
Who cannot join
- For Healthy volunteers:
- Current pregnancy, lactation or women not currently using medically acceptable birth control. (All women of childbearing age will be required to have a screening urine or blood pregnancy test)
- Contraindication to MRI scanning including individuals with the following devices:
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator prior to enrollment
Show all 36Show fewer
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Insulin pump
- Metal shrapnel or bullet
- Contraindications to MRI contrast agent administration:
- Inability to provide informed written consent for participation in the study.
- Chronic, medically refractory atrial tachyarrhythmias
- Symptoms of heart failure
- Mean PA greater than 25 mmHg or PVR greater than 1.5 wood units, or PCWP greater than 15 mmHg
- History of recreational drug use with the exception of marijuana. No Marijuana use within 3 months of protocol screening through completion of the study.
- Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.
- For HIV Positive Volunteers:
- Current pregnancy, lactation or women not currently using medically acceptable birth control.
- Active, untreated opportunistic infection with the exception of oral thrush or neoplasm with the exception of Kaposi's Sarcoma.
- Any of the following medical conditions:
- Severe renal insufficiency (on hemodialysis or serum creatinine greater than 2.5 mg/dl) or (CrCl less than 20 ml/min).
- Severe coagulopathy (platelets less than 100,000, PT INR greater than 1.5, PTT greater than 40 s)
- Chronic, medically refractory atrial tachyarrhythmias
- Current recreational drug use or use within 4 weeks of protocol screening with the exception of marijuana
- Contraindication to MRI scanning including individuals with the following devices:
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator prior to enrollment
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Insulin pump
- Metal shrapnel or bullet
- Contraindications to MRI contrast agent administration:
- Individuals with hemoglobinopathies
- Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Endothelial and Hemodynamic Function in HIV Associated Pulmonary Hypertension and a Phase I/II Safety and Efficacy Trial of Sildenafil in HIV Associated Pulmonary Hypertension
This study will examine how blood pressure in the lungs is controlled in healthy people, people with HIV and people with HIV and pulmonary artery hypertension (high blood pressure in the lungs, also called PAH). PAH sometimes develops in people with HIV, but it is not known why this occurs or how best to treat it.
Healthy volunteers and patients with HIV infection who are 18 years of age or older may be eligible for this study. All candidates are screened with a medical history, physical examination, electrocardiogram (EKG), chest x-ray, echocardiogram and blood tests. Participants undergo the following procedures:
Read more
All participants have a right heart catheterization and forearm blood flow study.
- Catheterization study. A catheter (plastic tube) is placed in an arm vein and possibly in an artery in the arm. Then a large catheter is passed through a vein in the groin, neck or chest. Through this "introducer" catheter, another catheter is advanced into the right side of the heart and to the pulmonary artery. A facemask is put in place to measure the amount of nitric oxide produced by the lungs. Acetylcholine is infused through the catheter and its effects on blood pressure in the lungs and on the amount of nitric oxide exhaled is measured. After about 1 hour, the catheter and facemask are removed and a new catheter is inserted through the introducer catheter into the pulmonary artery. The subject is moved into an MRI scanner where blood flow is measured after infusion of three different medications: acetylcholine (causes blood vessels to expand and slows heart rate); sodium nitroprusside (causes blood vessels to expand and increases blood flow to the heart); and L-NMMA (decreases blood flow by blocking production of nitric oxide in cells lining the blood vessels).
- Blood flow study. Small tubes are inserted into the artery of the patient's forearm. These are used to infuse medicines and draw blood samples. Forearm blood flow is measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood flows into the arm, stretching the strain gauge, and the flow measurement is recorded. A small lamp is positioned over the hand to measure the light reflected from the hand and blood flow in the forearm. Blood samples are then drawn to measure blood counts and proteins and other natural body chemicals. Then, forearm blood flow is measured after administration of small doses of sodium nitroprusside, acetylcholine and L-NMMA. There is a 20- to 30-minute rest period between injections of the different drugs.
In addition, HIV-infected patients with PAH undergo the following tests to determine the cause of their PAH: CT scan of the lungs, pulmonary function tests, 6-minute walk test, quality-of-life assessment, assessment of difficulty in breathing, exercise testing while measuring oxygen breathed in and carbon dioxide breathed out, blood tests, monitoring of oxygen saturation during sleep for 1 night and ventilation/perfusion scan. For the ventilation/perfusion scan, the subject breathes in a small amount of radioactive aerosol while images are obtained of the radioactivity as it enters the lungs, and then pictures of the lungs are taken from multiple angles. Next, the patient receives an injection of tiny particles of albumin (a protein) containing a small amount of radioactivity and pictures of the lungs are taken that show the pattern of blood flow to the lungs.
Patients with HIV and PAH who may benefit from the investigational drug, sildenafil (commonly known as Viagra), may continue to participate in the next stage of the study. They receive the first dose of sildenafil after completing the forearm blood flow study. They continue the drug for 16 weeks, returning to the clinic 1 week after the first dose and then every other week to monitor the response to treatment and drug side effects. At the end of 16 weeks, patients return to the clinic for a repeat evaluation, including blood tests, 6-minute walk test, echocardiogram, right heart catheterization and forearm blood flow study.
...
Read the detailed description
HIV infection has been associated with an increased prevalence of pulmonary hypertension. In addition, recent data suggests that a state of endothelial dysfunction develops in HIV disease secondary to anti-retroviral therapy and associated dyslipidemia or secondary to direct viral infection of the endothelium. This leads to premature atherosclerosis and possibly contributes to avascular necrosis of the hip. Similar effects on the pulmonary vasculature may be involved in the development of pulmonary vasculopathy.
In this study we plan to invasively characterize the status of pulmonary and systemic endothelial function and determine the mechanisms of pulmonary vascular endothelial dysfunction in HIV disease. To this end we will catheterize healthy volunteers and volunteers with HIV infection with and without pulmonary hypertension and directly measure acetylcholine-dependent blood flow in the pulmonary and brachial artery to assess pulmonary and systemic endothelium-dependent blood flow. Simultaneous measurement of exhaled NO and pulmonary capillary artery NO2 - will allow for complete characterization of the contribution of NO production to endothelium-dependent vasomotor control. We will also use recently developed MRI techniques to measure pulmonary artery blood flow during infusion of acetylcholine (ACH), sodium nitroprusside (SNP) and NG monomethyl-L-arginine (LNMMA) to establish responsiveness to an endothelium dependent vasodilator, endothelium-independent vasodilator and an NO inhibitor, respectively. Volunteers with pulmonary hypertension will have the option to undergo open label phase I/II treatment with sildenafil for 16 weeks and return for a repeat assessment of pulmonary hemodynamics as well as pulmonary and systemic endothelial function.
Endothelial cells will be isolated using novel flow-cytometry methodologies developed over the last two years at the NIH intramural division utilizing combinations of positive and negative selection based on specific surface markers for activated T cells and endothelial cells and markers of cell viability. Endothelial cells will subsequently be interrogated using amplified real time PCR methodologies and affymetrix based gene expression profiling developed in our laboratories. The levels of expression in endothelial cells of HIV virus, HHV8, eNOS, caveolin, HO-1, endothelin receptors A and B, and endothelin 1, in addition to other proteins regulating vascular homeostasis and cellular host defense (i.e. epidermal growth factor, transforming growth factor beta, platelet derived growth factor and interleukin-6), will be assessed.
These studies will provide insights into the mechanisms of pulmonary artery endothelial dysfunction and suggest rationally designed therapies targeting viral load, HHV8, and/or the NO/endothelin pathways. These studies have the promise of opening the door to the study of pulmonary artery endothelial dysfunction at the physiological, cellular and molecular level.
- Conditions
- HIV
- Being tested
- MRI, L-NMMA, Acetylcholine
- Keywords
- HIV, AIDS, Pulmonary Hypertension, Blood Flow Studies, Right Heart Catheterization, HIV Infection, HIV Associated Pulmonary Hypertension, Healthy Volunteer, HV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hypertension, Pulmonary, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
L-NMMADrug
AcetylcholineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate pulmonary artery and systemic endothelial function in HIV infected volunteers with pulmonary hypertension in comparison to HIV infected volunteers without pulmonary hypertension.
Secondary outcomes (1)
Evaluate the safety and efficacy of sildenafil in the treatment of hemodynamic and functional abnormalities in volunteers with HIV associated pulmonary hypertension.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study start12 May 2006
- Primary completion18 Mar 2009
- Study completion18 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Henry Masur, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327080
- Sponsor's protocol ID
- 060165
- Other IDs
- 06-H-0165
- Status last verified
- 13 Nov 2012
- First submitted
- 17 May 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Opravil M, Pechere M, Speich R, Joller-Jemelka HI, Jenni R, Russi EW, Hirschel B, Luthy R. HIV-associated primary pulmonary hypertension. A case control study. Swiss HIV Cohort Study. Am J Respir Crit Care Med. 1997 Mar;155(3):990-5. doi: 10.1164/ajrccm.155.3.9117037.
PubMed 9117037Zuber JP, Calmy A, Evison JM, Hasse B, Schiffer V, Wagels T, Nuesch R, Magenta L, Ledergerber B, Jenni R, Speich R, Opravil M; Swiss HIV Cohort Study Group. Pulmonary arterial hypertension related to HIV infection: improved hemodynamics and survival associated with antiretroviral therapy. Clin Infect Dis. 2004 Apr 15;38(8):1178-85. doi: 10.1086/383037. Epub 2004 Apr 1.
PubMed 15095226Nunes H, Humbert M, Sitbon O, Morse JH, Deng Z, Knowles JA, Le Gall C, Parent F, Garcia G, Herve P, Barst RJ, Simonneau G. Prognostic factors for survival in human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med. 2003 May 15;167(10):1433-9. doi: 10.1164/rccm.200204-330OC. Epub 2003 Feb 25.
PubMed 12615632
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endothelial and Hemodynamic Function in HIV Associated Pulmonary Hypertension and a Phase I/II Safety and Efficacy Trial of Sildenafil in HIV Associated Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00327080
- Acronym / sponsor ID
- 060165
- Conditions
- HIV
- Keywords
- HIV, AIDS, Pulmonary Hypertension, Blood Flow Studies, Right Heart Catheterization, HIV Infection, HIV Associated Pulmonary Hypertension, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 12 May 2006
- Primary completion
- 18 Mar 2009 (actual)
- Study completion
- 18 Mar 2009 (actual)
- First posted
- 18 May 2006 (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.
This study will examine how blood pressure in the lungs is controlled in healthy people, people with HIV and people with HIV and pulmonary artery hypertension (high blood pressure in the lungs, also called PAH). PAH sometimes develops in people with HIV, but it is not known why this occurs or how best to treat it.
Healthy volunteers and patients with HIV infection who are 18 years of age or older may be eligible for this study. All candidates are screened with a medical history, physical examination, electrocardiogram (EKG), chest x-ray, echocardiogram and blood tests. Participants undergo the following procedures:
All participants have a right heart catheterization and forearm blood flow study.
- Catheterization study. A catheter (plastic tube) is placed in an arm vein and possibly in an artery in the arm. Then a large catheter is passed through a vein in the groin, neck or chest. Through this "introducer" catheter, another catheter is advanced into the right side of the heart and to the pulmonary artery. A facemask is put in place to measure the amount of nitric oxide produced by the lungs. Acetylcholine is infused through the catheter and its effects on blood pressure in the lungs and on the amount of nitric oxide exhaled is measured. After about 1 hour, the catheter and facemask are removed and a new catheter is inserted through the introducer catheter into the pulmonary artery. The subject is moved into an MRI scanner where blood flow is measured after infusion of three different medications: acetylcholine (causes blood vessels to expand and slows heart rate); sodium nitroprusside (causes blood vessels to expand and increases blood flow to the heart); and L-NMMA (decreases blood flow by blocking production of nitric oxide in cells lining the blood vessels).
- Blood flow study. Small tubes are inserted into the artery of the patient's forearm. These are used to infuse medicines and draw blood samples. Forearm blood flow is measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood flows into the arm, stretching the strain gauge, and the flow measurement is recorded. A small lamp is positioned over the hand to measure the light reflected from the hand and blood flow in the forearm. Blood samples are then drawn to measure blood counts and proteins and other natural body chemicals. Then, forearm blood flow is measured after administration of small doses of sodium nitroprusside, acetylcholine and L-NMMA. There is a 20- to 30-minute rest period between injections of the different drugs.
In addition, HIV-infected patients with PAH undergo the following tests to determine the cause of their PAH: CT scan of the lungs, pulmonary function tests, 6-minute walk test, quality-of-life assessment, assessment of difficulty in breathing, exercise testing while measuring oxygen breathed in and carbon dioxide breathed out, blood tests, monitoring of oxygen saturation during sleep for 1 night and ventilation/perfusion scan. For the ventilation/perfusion scan, the subject breathes in a small amount of radioactive aerosol while images are obtained of the radioactivity as it enters the lungs, and then pictures of the lungs are taken from multiple angles. Next, the patient receives an injection of tiny particles of albumin (a protein) containing a small amount of radioactivity and pictures of the lungs are taken that show the pattern of blood flow to the lungs.
Patients with HIV and PAH who may benefit from the investigational drug, sildenafil (commonly known as Viagra), may continue to participate in the next stage of the study. They receive the first dose of sildenafil after completing the forearm blood flow study. They continue the drug for 16 weeks, returning to the clinic 1 week after the first dose and then every other week to monitor the response to treatment and drug side effects. At the end of 16 weeks, patients return to the clinic for a repeat evaluation, including blood tests, 6-minute walk test, echocardiogram, right heart catheterization and forearm blood flow study.
...
Detailed description
HIV infection has been associated with an increased prevalence of pulmonary hypertension. In addition, recent data suggests that a state of endothelial dysfunction develops in HIV disease secondary to anti-retroviral therapy and associated dyslipidemia or secondary to direct viral infection of the endothelium. This leads to premature atherosclerosis and possibly contributes to avascular necrosis of the hip. Similar effects on the pulmonary vasculature may be involved in the development of pulmonary vasculopathy.
In this study we plan to invasively characterize the status of pulmonary and systemic endothelial function and determine the mechanisms of pulmonary vascular endothelial dysfunction in HIV disease. To this end we will catheterize healthy volunteers and volunteers with HIV infection with and without pulmonary hypertension and directly measure acetylcholine-dependent blood flow in the pulmonary and brachial artery to assess pulmonary and systemic endothelium-dependent blood flow. Simultaneous measurement of exhaled NO and pulmonary capillary artery NO2 - will allow for complete characterization of the contribution of NO production to endothelium-dependent vasomotor control. We will also use recently developed MRI techniques to measure pulmonary artery blood flow during infusion of acetylcholine (ACH), sodium nitroprusside (SNP) and NG monomethyl-L-arginine (LNMMA) to establish responsiveness to an endothelium dependent vasodilator, endothelium-independent vasodilator and an NO inhibitor, respectively. Volunteers with pulmonary hypertension will have the option to undergo open label phase I/II treatment with sildenafil for 16 weeks and return for a repeat assessment of pulmonary hemodynamics as well as pulmonary and systemic endothelial function.
Endothelial cells will be isolated using novel flow-cytometry methodologies developed over the last two years at the NIH intramural division utilizing combinations of positive and negative selection based on specific surface markers for activated T cells and endothelial cells and markers of cell viability. Endothelial cells will subsequently be interrogated using amplified real time PCR methodologies and affymetrix based gene expression profiling developed in our laboratories. The levels of expression in endothelial cells of HIV virus, HHV8, eNOS, caveolin, HO-1, endothelin receptors A and B, and endothelin 1, in addition to other proteins regulating vascular homeostasis and cellular host defense (i.e. epidermal growth factor, transforming growth factor beta, platelet derived growth factor and interleukin-6), will be assessed.
These studies will provide insights into the mechanisms of pulmonary artery endothelial dysfunction and suggest rationally designed therapies targeting viral load, HHV8, and/or the NO/endothelin pathways. These studies have the promise of opening the door to the study of pulmonary artery endothelial dysfunction at the physiological, cellular and molecular level.
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 (21 listed)
- All volunteer subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and exclusion criteria.
- Males or females, 18 years of age or older.
- No history of HIV infection.
- EKG and echocardiogram with no evidence of clinical relevant heart disease (including TRV less than 2.5 m/s)
- No history of causes of pulmonary hypertension such as collagen vascular disease, chronic liver disease with ALT or AST greater than 2 times the upper limit of normal or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, or pulmonary parenchymal disease with hypoxemia.
Key exclusion criteria (36 listed)
- Current pregnancy, lactation or women not currently using medically acceptable birth control. (All women of childbearing age will be required to have a screening urine or blood pregnancy test)
- Contraindication to MRI scanning including individuals with the following devices:
- Contraindications to MRI contrast agent administration:
- Inability to provide informed written consent for participation in the study.
- Chronic, medically refractory atrial tachyarrhythmias
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 |
|---|---|---|
| MRI | Procedure or surgery | – |
| L-NMMA | Drug | – |
| Acetylcholine | Drug | – |
Primary outcome
Evaluate pulmonary artery and systemic endothelial function in HIV infected volunteers with pulmonary hypertension in comparison to HIV infected volunteers without pulmonary hypertension.
1 secondary outcome
Evaluate the safety and efficacy of sildenafil in the treatment of hemodynamic and functional abnormalities in volunteers with HIV associated pulmonary hypertension.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 9117037Opravil M, Pechere M, Speich R, Joller-Jemelka HI, Jenni R, Russi EW, Hirschel B, Luthy R. HIV-associated primary pulmonary hypertension. A case control study. Swiss HIV Cohort Study. Am J Respir Crit Care Med. 1997 Mar;155(3):990-5. doi: 10.1164/ajrccm.155.3.9117037.
- Background: PubMed 15095226Zuber JP, Calmy A, Evison JM, Hasse B, Schiffer V, Wagels T, Nuesch R, Magenta L, Ledergerber B, Jenni R, Speich R, Opravil M; Swiss HIV Cohort Study Group. Pulmonary arterial hypertension related to HIV infection: improved hemodynamics and survival associated with antiretroviral therapy. Clin Infect Dis. 2004 Apr 15;38(8):1178-85. doi: 10.1086/383037. Epub 2004 Apr 1.
- Background: PubMed 12615632Nunes H, Humbert M, Sitbon O, Morse JH, Deng Z, Knowles JA, Le Gall C, Parent F, Garcia G, Herve P, Barst RJ, Simonneau G. Prognostic factors for survival in human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med. 2003 May 15;167(10):1433-9. doi: 10.1164/rccm.200204-330OC. Epub 2003 Feb 25.
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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.
Henry Masur, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI, L-NMMA and Acetylcholine in people with HIV, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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 21 inclusion and 36 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Evaluate pulmonary artery and systemic endothelial function in HIV infected volunteers with pulmonary hypertension in comparison to HIV infected volunteers without pulmonary hypertension.. 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 NCT00327080, which also lists 3 linked publications.
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 17 Dec 2019.