Resistance in HIV+ in North and South

NCT02507921 | Unknown

• 1 other identifier: ST/0112/15
• Study Type: observational
• Target: 2,750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Drug Resistance

Outcome Measures

Primary Outcomes (2)

• HIV drug resistance in treatment-naive patients

  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

  up to 12hrs

• HIV drug resistance in treatment-experienced patients

  • 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

  up to 12hrs

Secondary Outcomes (4)

• Viroligical failure

  up to 12hrs

• Viroligical failure

  up to 12hrs

• Viroligical failure

  up to 12hrs

• Viroligical failure

  up to 12hrs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be all HIV-1 infected adults presenting to the Infectious Disease Institute in Kampala during a defined study period, who are either treatment naïve or have been on a stable antiretroviral regimen for longer than 6 months.

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study.
• Participants who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
• Age ≥ 18 years
• ART naïve OR on stable ART regimen ≥ 6 months (first- or second-line)

Sponsors & Collaborators

• Infectious Diseases Institute: lead
• University of Zurich: collaborator

Study Sites (1)

Infectious Diseases Institute, Makerere University

Kampala, 22418, Uganda

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for HIV viral load and serum for storage

Central Study Contacts

Amrei von Braun, MD

CONTACT

+256-414-307000; abraun@idi.co.ug

Christine Sekaggya-Wiltshire, MMED

CONTACT

+256312307000; csekaggya@idi.co.ug

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: July 24, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

UG (1)