Condition category
Infections and Infestations
Date applied
18/07/2012
Date assigned
13/08/2012
Last edited
12/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to find out whether there is more HIV virus in the genital secretions (in other words in semen or in vaginal fluid) than in the blood of patients participating in the EARNEST study. This will help us to understand how well different second-line treatments are working in different parts of the body. We also want to find out whether the virus in the genital secretions is different to the virus in the blood. These differences may alter the way the virus in the genital secretions responds to future HIV drugs. For example, the HIV virus may have changed in a way that it will no longer respond to a certain HIV drug; this is referred to as the virus being resistant to this HIV drug.

Who can participate?
Participants in the EARNEST study (i.e., HIV-infected adults who have taken a first-line nucleoside reverse transcriptase inhibitor [NRTI]-based regimen for at least 2 years and have developed treatment failure).

What does the study involve?
Patients will be asked to provide a genital secretions sample at week 96 of the main EARNEST study and, where applicable, at the time of second-line treatment failure. Men will be asked to produce a semen sample by masturbation either at home immediately before leaving for the clinical appointment or at the clinic (depending of the availability of suitable area at the clinic for this purpose and participant preferences). Women will be given instructions on how to obtain a self-swab. Alternatively, a sample of vaginal fluids will be taken in the clinic by a doctor or a nurse using a swab by speculum examination. The latter procedure would not differ from a regular vaginal examination and should not last for longer than 10 minutes.

What are the possible benefits and risks of participating?
The study will help us to learn more about the effects of different treatments on HIV in genital secretions. At the end of the EARNEST study and after all the samples have been analysed, the participant’s doctor will be provided with the results of the genital secretion resistance tests. Although this is unlikely to affect the participant’s medical treatment, the results may be discussed by the doctor and participant and this may be of interest to the participant. Discomfort can result from the vaginal examination, but this lasts for a short time. This will not be different from discomfort experienced in the past when having a speculum vaginal examination. The participant should be able to go home as soon as the procedure is completed.

Where is the study run from?
The study will be run at nine of the sites in Uganda that are taking part in the EARNEST study. The main site is JCRC Kampala.

When is the study starting and how long is it expected to run for?
The study started in July 2012 and recruitment will continue until January 2014.

Who is funding the study?
The Istituto Superiore di Sanita (ISS), Italy.

Who is the main contact?
Dr Nicolas Paton
EARNEST@ctu.mrc.ac.uk

Trial website

http://earnest.cineca.org/

Contact information

Type

Scientific

Primary contact

Prof Nicholas Paton

ORCID ID

Contact details

Department of Medicine
Yong Loo Lin School of Medicine
NUHS Tower Block Level 10
1E Kent Ridge Road
Singapore
119228
Singapore
+65 6772 6988
N.Paton@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.0 - 07 December 2011

Study information

Scientific title

Determination of viral load concentrations and drug resistance profiles in genital secretions of EARNEST patients and comparison to viral load concentrations and drug resistance profiles in plasma

Acronym

EARNEST GSS II

Study hypothesis

Human immunodeficiency virus (HIV) is transmitted primarily through vaginal and anal intercourse, and a high concentration of HIV in semen and cervico-vaginal fluid is one factor likely to increase sexual transmission from infected individuals to their sex partners. As the genital fluids and blood are separate immunologic compartments, if HIV replication is not suppressed sufficiently it may evolve differently in the genital and blood compartments and this may result in a different spectrum of drug resistance associated mutations. This substudy of the EARNEST trial (ISRCTN37737787 ) therefore aims to determine the level to which the three different boosted protease inhibitor (bPI) containing second-line treatment regimens used in EARNEST are suppressing viral replication in genital secretions and to compare the magnitude of viral replication in genital secretions with the magnitude of viral replication in the plasma of these patients. For those patients with a detectable viral load the drug resistance profile in genital secretions will be compared to the drug resistance profile in plasma.

Ethics approval

Institutional Review Board, Uganda, 23 February 2012

Study design

Cross-sectional substudy of EARNEST

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human immunodeficiency virus (HIV)

Intervention

This substudy is observational and there are hence no interventions. Patients will be asked to provide a genital secretions sample at week 96 of the main EARNEST trial and, where applicable, at the time of second-line treatment failure.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

This substudy of the EARNEST trial aims to determine the level to which the three different bPI-containing second-line treatment regimens used in EARNEST are suppressing viral replication in genital secretions (at week 96). For patients with a detectable viral load at week 96 the magnitude of viral replication in genital secretions will be compared with the magnitude of viral replication in plasma and the drug resistance profile in genital secretions will be compared to the drug resistance profile in plasma.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

11/07/2012

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Have been enrolled and are being followed as part of the main EARNEST trial
2. Have provided written informed consent to participate in this EARNEST substudy
3. Patients should be on the treatment regimen assigned at randomisation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

11/07/2012

Recruitment end date

31/01/2014

Locations

Countries of recruitment

Uganda

Trial participating centre

Department of Medicine
Singapore
119228
Singapore

Sponsor information

Organisation

Medical Research Council [MRC] Clinical Trials Unit (UK)

Sponsor details

Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
+44 (0)20 7670 4700
jvb@ctu.mrc.ac.uk

Sponsor type

Research council

Website

http://www.ctu.mrc.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health (Istituto Superiore di Sanita) [ISS] (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes