CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)

Completed · Phase 1

Conditions studied: HIV, Inflammation

In brief

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.

Key facts

Study ID

NCT02652546

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

38

Starts

2016-01-09

Expected to finish

2018-11-02

Last updated by the study team

2018-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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