Early administration of anti-latency reversing therapy and broadly neutralizing antibodies to limit the establishment of the HIV-1 reservoir during initiation of antiretroviral treatment - a randomized controlled trial – eCLEAR

Phase 1

• Conditions: HIV persistence during initiation of antiretroviral therapy; MedDRA version: 20.1 Level: LLT Classification code 10073675 Term: HIV infection CDC category unspecified System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002234-53-GB
• Lead Sponsor: Department of Infectious Diseases, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Documented HIV-1 infection
-No current or prior antiretroviral therapy
-Age >18 years
-CD4+ T-cell count >200/µL on last visit prior to study entry
-Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-Current immunosuppressive therapy
-Ongoing AIDS-defining condition
-Pregnancy as determined by a positive urine beta-hCG (if female).
-Participant unwilling to use reliable contraception methods for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female).
-Currently breast-feeding (if female).
-Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia).
-Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood
-Unable to follow protocol regimen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified