Europe - Africa Research Network for Evaluation of Second-line Therapy (EARNEST) Genital Secretions Substudy II

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN57333945

Enrollment

200

Registered

2012-08-13

Start date

2012-07-11

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus [HIV] disease

Interventions

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 ti

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026