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HIV-1 evolution after transmission. A cohort study to identify evolution of recently transmitted HIV-1 infection.


- candidate number5322
- NTR NumberNTR1632
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2009
- Secondary IDs09/007 MEC AMC
- Public TitleHIV-1 evolution after transmission. A cohort study to identify evolution of recently transmitted HIV-1 infection.
- Scientific TitleHIV-1 evolution after transmission. A cohort study to identify evolution of recently transmitted HIV-1 infection.
- ACRONYMHIV evolution after transmission
- hypothesisThe aim of this study is to examine the dynamics of escape mutations and reversions in relation to the Human Leukocyte antigen (HLA) type of the HIV-1 donor and the HLA type of the HIV-1 recipient. In addition, the HIV-1 sequence dynamics in relation to the specificity of the humoral immune response in HIV donor-recipient pairs will be studied. Since the donor most likely has an established immune response mounted against HIV-1 whilst the recipient does not, it may be expected that different viruses will propagate and different cell types will become infected. Hence, the virus in both donor and recipient pairs will be investigated as close as possible to the time of transmission. Simultaneously, the cellular compartments in which HIV resides and replicates will be analyzed.
- Healt Condition(s) or Problem(s) studiedPrimaire HIV-1 infection
- Inclusion criteria1. HIV-1 infected partners who are assumed to be the source of HIV-1 transmission (donor) of patients who present with primary HIV-1 infection at the ‘Primo-SHM’ study (recipient) in the AMC;
2. At least 18 years of age.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-feb-2012
- Target number of participants30
- InterventionsVenapuncture done twice with 128 ml blood extraction each time.
- Primary outcome1. Sequence of the viral genome that is present in the HIV-1 donor as close as possible to the time of HIV-1 transmission;
2. Virus diversity in the donor-recipient pairs half a year after HIV-1 transmission;
3. HLA type of donor-recipient pairs, availability of replication competent (pseudo)viruses from donor and recipient.
- Secondary outcomeThe relation between viral sequence dynamics and:
1. The HLA type of donor and recipient;
2. The autologous neutralization profile;
3. Host CTL responses;
4. Viral fitness.
- Timepoints1. Screening;
2. Visit 1: baseline;
3. Visit 2: 24 wks after baseline.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.M. Prins
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Prins
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIt is known that HIV-1 variants escape cellular and humarol immunity in the host. This may however have an impact on viral fitness and as a consequence, escape mutations will revert in the face of declining immunity or upon transmission to a new host. The aim of this study is to examine the dynamics of escape mutations and reversions in relation to the HLA type of the HIV-1 donor and the HLA type of the HIV-1 recipient. In addition, the same HIV-1 sequence dynamics in relation to the specificity of the humoral immune response in HIV-1 donor-recipient pairs will be studied.
- Main changes (audit trail)
- RECORD16-feb-2009 - 9-sep-2009


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