Clinical Trial Results:
Investigation of a novel intervention in Acute HIV infection (AHI) on long term latent HIV reservoir size: A pilot study of antiretroviral therapy plus immunoglobulin in AHI
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Summary
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EudraCT number |
2011-001982-42 |
Trial protocol |
GB |
Global end of trial date |
30 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Dec 2018
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First version publication date |
06 Dec 2018
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Other versions |
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Summary report(s) |
FINAL STUDY REPORT |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
J004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Guy's and St Thomas' NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE19RT
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Public contact |
Julie Fox, Guy's & St. Thomas' NHS Foundation Trust, +44 207188 2643, julie.fox@gstt.nhs.uk
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Scientific contact |
Julie Fox, Guy's & St. Thomas' NHS Foundation Trust, +44 207188 2643, julie.fox@gstt.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Mar 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Mar 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate whether reactivation of HIV using immunoglobulin in individuals with AHI and virologically suppressed with ART, will reduce HIV viral reservoir at week 48.
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Protection of trial subjects |
Safety blood tests (FBC, Urea and electrolytes and liver function tests) and adherence review are incorporated into the visit schedule. Any abnormalities or concerns will be addressed immediately and reported.
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Background therapy |
NONE | ||
Evidence for comparator |
INCLUSION CRITERIA Males and females aged between 18-65 years (inclusive). 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) Ability and willingness to provide informed consent | ||
Actual start date of recruitment |
05 Jul 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
10
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from one clinical site in London between 2013 to 2015 | |||||||||
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Pre-assignment
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Screening details |
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 | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
At week 20 post commencemnet on ART therapy, participants are randomized to receive 5 days treatment with IVIG or no IVIG.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ARM B - IVIG Intervention | |||||||||
Arm description |
Participants randomised at week 20 post commencement on ART to receive 30g IVIG per day for five days | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IVIG
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Investigational medicinal product code |
OCTAGAM
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
30mg per day for 5 days
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Arm title
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ARM A - NO IVIG INTERVENTION | |||||||||
Arm description |
Randomised at 20 weeks post commencement on ante retro viral therapy to NOT receive IVIG | |||||||||
Arm type |
CONTROL | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ARM B - IVIG Intervention
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Reporting group description |
Participants randomised at week 20 post commencement on ART to receive 30g IVIG per day for five days | ||
Reporting group title |
ARM A - NO IVIG INTERVENTION
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Reporting group description |
Randomised at 20 weeks post commencement on ante retro viral therapy to NOT receive IVIG | ||
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End point title |
Primary Endpoint [1] | |||||||||
End point description |
HIV viral reservoir - change in HIV proviral DNA quantification between enrolment and week 48
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End point type |
Primary
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End point timeframe |
48 weeks post commencment on ART
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached report for results |
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Attachments |
AHI RESULTS |
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End point title |
Secondary Endpoint | |||||||||
End point description |
Secondary outcome measures: measured as a comparison across arms between enrolment and week 48.
a. Changes in CD8 T-cell activation: the percentage of CD3+ CD8+ cells expressing CD38+
b. Gut permeability: 16S DNA
c. Host gene expression profiling
d. Clinical outcome: CD4 T-cell counts, CD4 T cell decline, HIV RNA e. Immunological markers of T cell exhaustion: HLA-DR and PD-1 f. Inflammation (D-dimer)
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End point type |
Secondary
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End point timeframe |
Until 48 weeks post commencment on ART
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Duration of the study
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
ARM A - NO IVIG INTERVENTION
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Reporting group description |
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Reporting group title |
ARM B - IVIG INTERVENTION
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 May 2014 |
Change in CI (to Julie Fox)
* Update label to reflect change back to JF as CI
* Multi-centre to single centre
* Remove Imperial site
*Clarification added to Hep B exclusion criteria |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
