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

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. 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.

Conditions

• HIV, Inflammation

Interventions

DRUG

Effect of drug on inflammatory biomarkers

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.

DRUG

Assess Safety

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

DRUG

Effect of drug on viral load

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

DRUG

Effect of drug on T-cell count

Evaluate the effect of CC-11050 on CD4+ T cell counts and percentages at week 12 and over all evaluable time points

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Irini Sereti, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-09

Primary Completion

2017-05-15

Completion

2018-11-02

FDA Drug

Yes

Countries

• United States

Study Locations