HIV, InflammationPhase 1NCT02652546
CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)
A Phase 1 study testing Assess Safety, Effect of drug on viral load and Effect of drug on T-cell count in people with HIV, Inflammation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: When there is a threat to the body, the immune system triggers inflammation. Too much inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick after they start HIV drugs because their recovering immune systems cause too much inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Inflammation
- What is being tested?
- Assess Safety, Effect of drug on viral load and Effect of drug on T-cell count
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2016to 2 Nov 2018
- 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
- Adults (greater than or equal to 18 years)
- Body mass index (BMI) less than or equal to 35 kg/m2
- On ART for a minimum of 1 year and on a stable regimen (according to DHHS guidelines) for at least 3 months prior to screening
- Plasma HIV-1 RNA level <50 copies/mL at screening (patients with 50-499 <500 copies/mL at screening may be asked to return for rescreening in four (4) weeks or later
- Men and women must be willing to take appropriate precautions to prevent pregnancy as described below
- Willingness to undergo genetic testing
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- Willingness to allow storage of specimens for future analysis
- Negative serum or urine pregnancy test (for women of childbearing potential)
- Under the care of a primary care physician outside of the NIH
- Contraception: The effects of CC-11050 on the developing human fetus are unknown. For this reason, subjects must agree to not become pregnant. Females of childbearing potential must have a pregnancy test before initiating the study agent and at each study visit. Because of the risk involved, male and female study participants who engage in sexual activities that can result in pregnancy must agree to use of a male or female condom at every potentially reproductive sexual encounter, AS WELL AS one of the other methods listed below, beginning at the baseline visit and continuing until 3 months after discontinuation of the study agent. Acceptable methods are as follows:
- Hormonal contraception [e.g. consistent use of oral contraceptive pill daily or other hormonal method such as contraceptive implant or injection] (must be started 1 month prior to receiving the first dose of study agent)
- Diaphragm or cervical cap
- Intrauterine device (IUD)
- Male partner with a vasectomy
- During the study, if a participant becomes pregnant or suspects they are pregnant, they should inform the study staff and their primary care physician immediately. The study medication will be stopped immediately and if on CC-11050 they will be referred to a high risk pregnancy specialist and followed by the study team for the remainder of the pregnancy or the rest of the study, whichever occurs later.
Who cannot join
- Body mass index (BMI) less than or equal to 18.5 kg/m2
- Protease inhibitor-based ART regimen
- ART regimen which includes Cobicistat
- Absence of alternate available ART options in case of virologic failure
- Serum ALT or AST value Grade >2 or total bilirubin greater than the ULN unless it is indirect due to Gilbert s disease
- History of chronic hepatitis B (+HbsAg or +HBV DNA in plasma) and/or C - treated chronic hepatitis C with SVR > 2 years will be accepted.
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- Cirrhosis of the liver, or any known active or chronic liver disease
- Recent history (<30 days) of infection requiring inpatient hospitalization or systemic therapy
- Depression. Patients who report depression or, are suspected or known to have depression and are on stable anti-depressants will undergo Psychiatry evaluation and clinical assessments to determine eligibility. These assesments will be done by a psychiatrist and may include: Beck Depression Inventory (BDI), Spielberger State-Trait Anxiety Inventory (STAI), Montreal Cognitive Assessment(MoCA). The BDI, STAI, and MoCA will be administered to patients being considered for study enrollment. The BDI and STAI may be repeated at least once during follow-up visits in those deemed eligible to participate.
- Current breastfeeding
- Current or anticipated treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (other than antiretrovirals approved for use in the treatment of HIV)
- Any experimental medications within 4 weeks prior to screening or anticipated use of such medications during the trial.
- Current (4 weeks prior to the first dose of study drug,) or anticipated use of antimetabolites; alkylating agents; or drugs other than ART, herbal preparations (including St. John s wort), and foods (including grapefruit) known to affect activity of the CYP3A4 enzyme pathway
- Use of thalidomide, lenalidomide, pomalidomide, systemic corticosteroids within 4 weeks of screening
- Any prior history of PDE4 inhibitor use
- History of pancreatitis, elevated lipase (less than or equal to 1.5 above the upper limit of normal) or triglyceride level >500 mg/dL.
- History of clinically significant metabolic, endocrine, hepatic, renal, hematologic, pulmonary, gastrointestinal, autoimmune or cardiovascular disorders
- Uncontrolled hypertension (persistent measurements over 140/90)
- Bradycardia, defined as a sinus rhythm <50 beats/min (bpm)
- History or presence of a clinically significant abnormal ECG
- History of malignancy except cured basal or squamous cell carcinoma of the skin or cutaneous Kaposi s sarcoma not requiring systemic therapy during the trial
- Receipt of radiation or cytotoxic chemotherapeutic agents, unless fully recovered from disease by the time of the first dose of study drug as determined by the opinion of the Investigator, or anticipated use of such agents during the study period
- Any condition or significant problems that, based on the judgment of the investigator, would increase risk to the subject or would interfere with the subject s ability to comply with protocol requirements.
- Co-enrollment Guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies or those evaluating the use of a licensed medication. Study staff should be notified of co-enrollment as it may require the approval of the study investigators.
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: A Phase 1 Study of CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy
Background:
When there is a threat to the body, the immune system triggers inflammation. Too much inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick after they start HIV drugs because their recovering immune systems cause too much inflammation. Or their immune systems can become activated all the time. This can cause serious health problems. Researchers want to test if the drug CC-11050 helps treat inflammation in people taking HIV drugs.
Read more
Objectives:
To test if CC-11050 is safe and well-tolerated for people with HIV who are taking HIV drugs. To see if it reduces inflammation.
Eligibility:
People ages 18 and older with HIV who have been on antiretroviral therapy for at least 1 year.
Design:
Participants will be screened with:
Medicine review
Physical exam and medical history
Blood and urine tests
Chest x-ray
Electrocardiogram (ECG): Soft electrodes on the skin record heart signals.
Participants will be randomly assigned to take capsules of either CC-11050 or a placebo. They will take the capsules every day for 12 weeks. They will continue to take their HIV drugs.
Participants will have a baseline visit within 2 months of screening. This includes:
Physical exam and medical history
Blood and urine tests
ECG
Leukapheresis: Blood is removed by a needle in one arm and passed through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm.
Participants will have follow-up visits 2, 4, 8, 12, and 16 weeks after the baseline visit. These may include repeats of some of the baseline tests.
Read the detailed description
CC-11050 is a novel anti-inflammatory compound with potential to treat a variety of chronic inflammatory conditions and cytokine storms associated with infectious diseases. CC-11050 is a selective phosphodiesterase-4 inhibitor (PDE4) that is active in several in vivo models of inflammatory disease, inhibiting systemic TNF- production, colitis symptoms of the colon, psoriasiform features in the skin, arthritogenic swelling in the joints, neutrophilia and eosinophilia in the lung, and reducing choroidal neovascularization. These data suggest that CC-11050 may have therapeutic potential for chronic inflammatory conditions and/or as an antiangiogenic treatment. The safety profile of CC-11050 has been investigated in healthy males and in subjects with cutaneous lupus erythematosus; the most frequently reported adverse events were fatigue, headache, upper respiratory infection and pruritus; there were no deaths or serious adverse events.
Inflammation is an important contributor to HIV pathogenesis both prior to and after ART initiation. Inflammatory responses can occur abruptly upon ART initiation (known as immune reconstitution inflammatory syndrome or IRIS) and can be chronic in persons with suppressed plasma HIV viremia who are treated with ART, and has been linked to an excess risk of non-AIDS serious events such as cardiovascular, liver and kidney disease and accelerated bone loss. Corticosteroids to reduce levels of inflammatory cytokines in plasma are a standard therapeutic intervention for IRIS, however a more targeted anti-inflammatory and less broadly immunosuppressive intervention is desirable.
We propose a double-blind, randomized trial to assess the safety of CC-11050 in adults with HIV infection who have taken ART for at least 1 year and have suppressed plasma viremia. Enrolled subjects will be randomized 2:1 to 200 mg CC-11050 or placebo twice daily for 12 weeks. Participants will be evaluated at weeks 0, 2, 4, 8, 12 and 16. Changes in in plasma HIV-1 RNA levels (by clinical assay), CD4+ T cell counts and percentages, and the effect on markers of systemic inflammation (e.g., TNF, IL-6, CRP, IFNg, sCD14, D-dimer) will be measured. The effect of CC-11050 on cellular immune activation (T cells and monocytes), and on viral reservoirs (cell associated HIV DNA and RNA) will also be assessed.
- Conditions
- HIV, Inflammation
- Being tested
- Assess Safety, Effect of drug on viral load, Effect of drug on T-cell count, Effect of drug on inflammatory biomarkers
- Keywords
- HIV/AIDS, Immune Activation, Anti-Inflammatory, TNF, Phosphodieterase Inhibitor
- Medical subject headings
- Inflammation, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess SafetyDrug
Assess the safety of a 12-week course if CC-1150 in HIV-infected adults who have been on ART for greater than or equal to 1 year and have suppressed plasma viremia
Effect of drug on viral loadDrug
Evaluate the effect of CC-11050 on plasma HIV-1 RNA levels by both conventional and single copy assay at week 12 and over all evaluable time points
Effect of drug on T-cell countDrug
Evaluate the effect of CC-11050 on CD4+ T cell counts and percentages at week 12 and over all evaluable time points
Effect of drug on inflammatory biomarkersDrug
Evaluate the effect of CC-11050 on markers of markers of systemic inflammation (TNF, IL-^, CRP, IFNg, sCD14, D-dimer) at week 12 and over all evaluable time points.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | CC-11050 200mg (2 capsules) BID with food Receives: Drug: Assess Safety; Drug: Effect of drug on viral load; Drug: Effect of drug on T-cell count; Drug: Effect of drug on inflammatory biomarkers |
| B | Placebo comparator | Placebo (2 capsules) BID with food Receives: Drug: Assess Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of AEs and SAEs in subjects receiving study agent vs placebo
Measured: 12/30/2016
Secondary outcomes (3)
Plasma HIV-1 RNA levels by both conventional and single-copy assay at Weeks 0,2,4,8, and 12
Measured: week 12
CD4+ T cell counts and percentages at weeks 2,4,8 and 12
Measured: week 12
Markers of systemic inflammation (TNF, IL-6, CRP, IFNy, sCD14, D-dimer) at weeks 2,4,8 and 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start9 Jan 2016
- Primary completion15 May 2017
- Study completion2 Nov 2018
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 HIV, InflammationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Irini Sereti, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652546
- Sponsor's protocol ID
- 160044
- Other IDs
- 16-I-0044
- Status last verified
- 2 Nov 2018
- First submitted
- 9 Jan 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Andrade BB, Singh A, Narendran G, Schechter ME, Nayak K, Subramanian S, Anbalagan S, Jensen SM, Porter BO, Antonelli LR, Wilkinson KA, Wilkinson RJ, Meintjes G, van der Plas H, Follmann D, Barber DL, Swaminathan S, Sher A, Sereti I. Mycobacterial antigen driven activation of CD14++CD16- monocytes is a predictor of tuberculosis-associated immune reconstitution inflammatory syndrome. PLoS Pathog. 2014 Oct 2;10(10):e1004433. doi: 10.1371/journal.ppat.1004433. eCollection 2014 Oct.
PubMed 25275318Schafer PH, Chen P, Fang L, Wang A, Chopra R. The pharmacodynamic impact of apremilast, an oral phosphodiesterase 4 inhibitor, on circulating levels of inflammatory biomarkers in patients with psoriatic arthritis: substudy results from a phase III, randomized, placebo-controlled trial (PALACE 1). J Immunol Res. 2015;2015:906349. doi: 10.1155/2015/906349. Epub 2015 Apr 20.
PubMed 25973439Marzi A, Feldmann H. Ebola virus vaccines: an overview of current approaches. Expert Rev Vaccines. 2014 Apr;13(4):521-31. doi: 10.1586/14760584.2014.885841. Epub 2014 Feb 27.
PubMed 24575870
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02652546
- Acronym / sponsor ID
- 160044
- Conditions
- HIV, Inflammation
- Keywords
- HIV/AIDS, Immune Activation, Anti-Inflammatory, TNF, Phosphodieterase Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Jan 2016
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 12 Jan 2016 (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.
Background:
When there is a threat to the body, the immune system triggers inflammation. Too much inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick after they start HIV drugs because their recovering immune systems cause too much inflammation. Or their immune systems can become activated all the time. This can cause serious health problems. Researchers want to test if the drug CC-11050 helps treat inflammation in people taking HIV drugs.
Objectives:
To test if CC-11050 is safe and well-tolerated for people with HIV who are taking HIV drugs. To see if it reduces inflammation.
Eligibility:
People ages 18 and older with HIV who have been on antiretroviral therapy for at least 1 year.
Design:
Participants will be screened with:
Medicine review
Physical exam and medical history
Blood and urine tests
Chest x-ray
Electrocardiogram (ECG): Soft electrodes on the skin record heart signals.
Participants will be randomly assigned to take capsules of either CC-11050 or a placebo. They will take the capsules every day for 12 weeks. They will continue to take their HIV drugs.
Participants will have a baseline visit within 2 months of screening. This includes:
Physical exam and medical history
Blood and urine tests
ECG
Leukapheresis: Blood is removed by a needle in one arm and passed through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm.
Participants will have follow-up visits 2, 4, 8, 12, and 16 weeks after the baseline visit. These may include repeats of some of the baseline tests.
Detailed description
CC-11050 is a novel anti-inflammatory compound with potential to treat a variety of chronic inflammatory conditions and cytokine storms associated with infectious diseases. CC-11050 is a selective phosphodiesterase-4 inhibitor (PDE4) that is active in several in vivo models of inflammatory disease, inhibiting systemic TNF- production, colitis symptoms of the colon, psoriasiform features in the skin, arthritogenic swelling in the joints, neutrophilia and eosinophilia in the lung, and reducing choroidal neovascularization. These data suggest that CC-11050 may have therapeutic potential for chronic inflammatory conditions and/or as an antiangiogenic treatment. The safety profile of CC-11050 has been investigated in healthy males and in subjects with cutaneous lupus erythematosus; the most frequently reported adverse events were fatigue, headache, upper respiratory infection and pruritus; there were no deaths or serious adverse events.
Inflammation is an important contributor to HIV pathogenesis both prior to and after ART initiation. Inflammatory responses can occur abruptly upon ART initiation (known as immune reconstitution inflammatory syndrome or IRIS) and can be chronic in persons with suppressed plasma HIV viremia who are treated with ART, and has been linked to an excess risk of non-AIDS serious events such as cardiovascular, liver and kidney disease and accelerated bone loss. Corticosteroids to reduce levels of inflammatory cytokines in plasma are a standard therapeutic intervention for IRIS, however a more targeted anti-inflammatory and less broadly immunosuppressive intervention is desirable.
We propose a double-blind, randomized trial to assess the safety of CC-11050 in adults with HIV infection who have taken ART for at least 1 year and have suppressed plasma viremia. Enrolled subjects will be randomized 2:1 to 200 mg CC-11050 or placebo twice daily for 12 weeks. Participants will be evaluated at weeks 0, 2, 4, 8, 12 and 16. Changes in in plasma HIV-1 RNA levels (by clinical assay), CD4+ T cell counts and percentages, and the effect on markers of systemic inflammation (e.g., TNF, IL-6, CRP, IFNg, sCD14, D-dimer) will be measured. The effect of CC-11050 on cellular immune activation (T cells and monocytes), and on viral reservoirs (cell associated HIV DNA and RNA) will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Assess Safety, Drug: Effect of drug on viral load, Drug: Effect of drug on T-cell count, Drug: Effect of drug on inflammatory biomarkersCC-11050 200mg (2 capsules) BID with food |
| B | Placebo comparator | Drug: Assess SafetyPlacebo (2 capsules) BID with food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Contraception: The effects of CC-11050 on the developing human fetus are unknown. For this reason, subjects must agree to not become pregnant. Females of childbearing potential must have a pregnancy test before initiating the study agent and at each study visit. Because of the risk involved, male and female study participants who engage in sexual activities that can result in pregnancy must agree to use of a male or female condom at every potentially reproductive sexual encounter, AS WELL AS one of the other methods listed below, beginning at the baseline visit and continuing until 3 months after discontinuation of the study agent. Acceptable methods are as follows:
- Hormonal contraception [e.g. consistent use of oral contraceptive pill daily or other hormonal method such as contraceptive implant or injection] (must be started 1 month prior to receiving the first dose of study agent)
- Diaphragm or cervical cap
- Intrauterine device (IUD)
- Male partner with a vasectomy
Key exclusion criteria (24 listed)
- Body mass index (BMI) less than or equal to 18.5 kg/m2
- Protease inhibitor-based ART regimen
- ART regimen which includes Cobicistat
- Absence of alternate available ART options in case of virologic failure
- Serum ALT or AST value Grade >2 or total bilirubin greater than the ULN unless it is indirect due to Gilbert s disease
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 |
|---|---|---|
| Assess SafetyAssess the safety of a 12-week course if CC-1150 in HIV-infected adults who have been on ART for greater than or equal to 1 year and have suppressed plasma viremia | Drug | A, B |
| Effect of drug on viral loadEvaluate the effect of CC-11050 on plasma HIV-1 RNA levels by both conventional and single copy assay at week 12 and over all evaluable time points | Drug | A |
| Effect of drug on T-cell countEvaluate the effect of CC-11050 on CD4+ T cell counts and percentages at week 12 and over all evaluable time points | Drug | A |
| Effect of drug on inflammatory biomarkersEvaluate the effect of CC-11050 on markers of markers of systemic inflammation (TNF, IL-^, CRP, IFNg, sCD14, D-dimer) at week 12 and over all evaluable time points. | Drug | A |
Primary outcome
Frequency and severity of AEs and SAEs in subjects receiving study agent vs placebo
Time frame: 12/30/2016
3 secondary outcomes
Plasma HIV-1 RNA levels by both conventional and single-copy assay at Weeks 0,2,4,8, and 12
Time frame: week 12
CD4+ T cell counts and percentages at weeks 2,4,8 and 12
Time frame: week 12
Markers of systemic inflammation (TNF, IL-6, CRP, IFNy, sCD14, D-dimer) at weeks 2,4,8 and 12
Time frame: week 12
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 6 Nov 2018.
- Background: PubMed 25275318Andrade BB, Singh A, Narendran G, Schechter ME, Nayak K, Subramanian S, Anbalagan S, Jensen SM, Porter BO, Antonelli LR, Wilkinson KA, Wilkinson RJ, Meintjes G, van der Plas H, Follmann D, Barber DL, Swaminathan S, Sher A, Sereti I. Mycobacterial antigen driven activation of CD14++CD16- monocytes is a predictor of tuberculosis-associated immune reconstitution inflammatory syndrome. PLoS Pathog. 2014 Oct 2;10(10):e1004433. doi: 10.1371/journal.ppat.1004433. eCollection 2014 Oct.
- Background: PubMed 25973439Schafer PH, Chen P, Fang L, Wang A, Chopra R. The pharmacodynamic impact of apremilast, an oral phosphodiesterase 4 inhibitor, on circulating levels of inflammatory biomarkers in patients with psoriatic arthritis: substudy results from a phase III, randomized, placebo-controlled trial (PALACE 1). J Immunol Res. 2015;2015:906349. doi: 10.1155/2015/906349. Epub 2015 Apr 20.
- Background: PubMed 24575870Marzi A, Feldmann H. Ebola virus vaccines: an overview of current approaches. Expert Rev Vaccines. 2014 Apr;13(4):521-31. doi: 10.1586/14760584.2014.885841. Epub 2014 Feb 27.
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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.
Irini Sereti, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Assess Safety, Effect of drug on viral load and Effect of drug on T-cell count in people with HIV, Inflammation, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 15 inclusion and 24 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 6 Nov 2018. 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. Some participants in this study may receive a placebo. 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 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?
Frequency and severity of AEs and SAEs in subjects receiving study agent vs placebo (time frame: 12/30/2016). 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 NCT02652546, 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 6 Nov 2018.