Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals

Completed

Conditions studied: HIV

In brief

Background: The immune system helps the body fight off disease. Most people infected with HIV cannot control the infection and need daily medicine. Combination antiretroviral therapy (cART) are drugs taken to prevent HIV infection from damaging the immune system. Researchers want to study why some people develop resistance to the drugs or have permanent side effects. Objective: To study the impact of a short-term treatment stop on HIV that persists even while taking cART. Eligibility: Adults 18-65 years old with HIV who are being treated with cART Design: * Participants will first be screened with a physical exam and medical history. They may have a chest x-ray. They will have heart, blood, and urine tests. * At the baseline visit, participants will repeat the screening tests except the x-ray. They will get counseling about HIV and risk behavior. * Participants will have leukapheresis. Blood will be removed through a needle in one arm. A machine will separate white blood cells from the rest of the blood. The remainder of the blood will be returned to the body by a different needle. * Participants will stop their current treatment on day 0. They will visit the clinic each week until they meet the criteria to restart cART. These visits will have the same procedures as the baseline visit. * Before restarting cART, most participants will have leukapheresis. * After restart, participants will be seen weekly for 4 weeks and then monthly for about 11 months. Participants will have blood drawn, physical exam, and medical history. They will have leukapheresis 2 more times over 1 year.

Key facts

Study ID: NCT03225118
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 29
Starts: 2017-07-17
Expected to finish: 2020-01-16
Last updated by the study team: 2020-01-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface antigen (HBsAg), an isolated positive Hepatitis B core antibody (negative HBsAg and anti-HBV Ab) and/or positive Hepatitis B virus (HBV) DNA.
Chronic hepatitis C virus (HCV) infection as evidenced by a positive test for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
Has a history of institution of ART within 12 weeks of being diagnosed with acute or early HIV-1, where acute/early infection is defined by any one of the following:
Positive HIV-1 enzyme immunoassay (EIA) with negative/indeterminate HIV-1 western blot that subsequently becomes positive
Negative HIV-1 EIA within the past 4 months and HIV-1 RNA levels of greater than 400,000 copies/mL, in the setting of a potential exposure to HIV-1.
Negative rapid HIV-1 within one month prior to a positive HIV-1 EIA and HIV-1 western blot
Low level HIV antibodies (positive EIA or western blot) with a non-reactive detuned EIA
Documented nadir CD4+ T cell count less than 200 cells /mm\^3
-Patients with a nadir CD4+ T cell count between 100-200 are not excluded, provided their current CD4+ T cell count has been >450 the past 3 years
--Subjects with dips (i.e., transient decreases in their CD4 count) prior to screening may be included provided they satisfy the following criteria:
a. The dips are > 350 cells/mL, and
b. Succeeding CD4 counts return to levels above 450 cells/mL on subsequent testing
Any history of AIDS defining opportunistic infections
Subjects with history of receiving ART consisting of mono or dual drug therapy
Documented multiclass antiretroviral drug resistance that, in the judgement of the investigator, would pose a risk of virologic failure should additional mutations develop during the study
Any experimental non-HIV vaccination received within 2 weeks prior to study enrollment and at any time during the study.
Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment/Day 0
Receipt of other investigational study agent within 28 days of enrollment/day 0 and at any time during the study
Any active malignancy that may require systemic chemotherapy or radiation therapy
Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded: (1)corticosteroid nasal spray or inhaler; (2) topical corticosteroids for mild, uncomplicated dermatitis; and (3) oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy less than or equal to 10 days, with completion in greater than or equal to 30 days prior to enrollment/day 0)
History of or other clinical evidence of:
Significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction)
Severe illness, malignancy, immunodeficiency other than HIV, active systemic infection other than HIV, or any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study
Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements
Both male and female subjects to remain completely abstinent of potentially reproductive sexual intercourse (e.g. due to a committed lifestyle) or to consistently use BOTH a barrier method with a spermicide (male or female condom) AND ALSO one of the below listed methods of birth control:

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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