A study of the effect of antiretroviral therapy and immunoglobulin on the HIV reservoir in Acute HIV Infection.

Phase 1

• Conditions: Acute HIV Infection; MedDRA version: 14.1 Level: LLT Classification code 10000811 Term: Acute infection with HIV System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-001982-42-GB
• Lead Sponsor: Guy's & St. Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-04
• Study Completion: 2015-03-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1)Males and females aged between 18-65 years (inclusive).
2)HIV antibody negative with p24/PCR DNA positive
OR
HIV antibody positive with a previous HIV negative test in the preceding 3 months
OR
Health Protection Agency HIV incident virus assay (estimating virus acquired within 3 months)
3)Ability and willingness to provide 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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1)HIV negative
2)Pregnancy or lactating: at enrolment, randomisation or during study period as there is no data on IVIG in pregnant HIV+ women.
3)Patient unable or unwilling to comply with trial protocol
4)Known hypersensitivity to the active substances or to any of the excipients of the IMP
5)Current use or likely to require use of concomitant medication with known
interactions with HAART regimen in accordance with SmPCs.
6)Hep B sAg positive at screening or prior to starting antiretroviral therapy (ARV)
7)Documented active Hepatitis C.
8)Previous documented pulmonary embolism (PE), deep vein thrombosis (DVT), myocardial infarction (MI) or cerebrovascular accident (CVA)
9)Women of childbearing potential unwilling to use barrier method contraception (condoms)
10) Sexually active males with female partners of childbearing potential, unwilling to use barrier method contraception (condoms)
11)Insulin dependant diabetes
12)Documented bleeding disorders (for gut sub study participants only)

Study & Design

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