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Report for Clinical Trial NCT02507921

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Comparing Type and Prevalence of HIV Drug Resistance in Treatment Experienced and naïve HIV-infected Adults in Uganda and Switzerland

The investigators aim to assess type and frequency of HIV drug resistance in adults presenting to the Infectious Diseases Institute (IDI) in Kampala, Uganda, and compare this data to patients from the Swiss HIV Cohort Study (SHCS). This study is a single-site, cross-sectional study. The Investigators' goal is to perform viral load measurements in 2750 HIV-infected patients who have been on ART for 6 months or more. Presuming a detectable viral load in 10%, resistance testing would then be performed in 250 patients on ART. All adult patients attending will be screened for enrollment. Furthermore, the investigators' goal is to perform resistance testing in 250 ART naive patients in order to detect transmitted resistance mutations. Investigators will therefore consecutively screen and enroll 250 ART naive patients who attend the clinic during the study period. For each participant, a case report form (CRF) form will be completed which includes social, as well as medical information. Investigators will ask each participant for permission to store plasma in case resistance testing must be repeated, and serum, in case of future research questions.

NCT02507921 HIV Drug Resistance


Primary Outcomes

Description: Type and frequency of transmitted HIV drug resistance mutations detected in treatment naive patients and comparison to naive patients in the Swiss HIV Cohort Study (SHCS) • Identification of risk factors associated with the occurrence of transmitted HIV drug resistance mutations in treatment-naive patients

Measure: HIV drug resistance in treatment-naive patients

Time: up to 12hrs

Description: • Type and frequency of HIV drug resistance mutations detected in patients on ART with virological failure and comparison to patients on treatment the Swiss HIV Cohort Study (SHCS) Identification of risk factors associated with the detection of HIV drug resistance mutations in treatment-experienced patients

Measure: HIV drug resistance in treatment-experienced patients

Time: up to 12hrs

Secondary Outcomes

Description: Proportion of HIV-infected patients with detectable viral load in the absence of immunological and/or clinical treatment failure

Measure: Viroligical failure

Time: up to 12hrs

Description: • Diagnostic performance of immunological/clinical criteria for the detection of treatment failure compared to virological testing (gold standard)

Measure: Viroligical failure

Time: up to 12hrs

Description: •Type and frequency of HIV drug resistance mutations detected in ART naive and experienced patients in Uganda and comparison to migrants from sub-Saharan Africa in the SHCS

Measure: Viroligical failure

Time: up to 12hrs

Description: •Assessment of local risk factors for treatment failure

Measure: Viroligical failure

Time: up to 12hrs

Time Perspective: Cross-Sectional

Cohort


There are 2 SNPs

SNPs


1 K103N

These analyses will be performed for all drug-resistance mutations pooled together (outcome-variable= patient has any drug resistance mutation), for drug resistance mutations against individual drug classes (outcome = patient has any drug resistance mutation to a particular drug class), and for the two resistance mutations (M184V and K103N) that have been most prevalent in previous studies in resource-limited settings. --- M184V --- --- K103N ---


2 M184V

These analyses will be performed for all drug-resistance mutations pooled together (outcome-variable= patient has any drug resistance mutation), for drug resistance mutations against individual drug classes (outcome = patient has any drug resistance mutation to a particular drug class), and for the two resistance mutations (M184V and K103N) that have been most prevalent in previous studies in resource-limited settings. --- M184V ---



HPO Nodes