NCT01853657

Brief Summary

The main objective is to access efficacy of first and second line antiretroviral therapy (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of second line ART in patients who were switched after virological failure compared to patients who were switched after clinical or immunological failure. Other specific study objectives are:

  1. 1.To establish an HIV Cohort Study at the study site.
  2. 2.To assess the rate of virological failure among patients on first line therapy
  3. 3.To compare the clinical, immunological and virological efficacy of second line antiretroviral therapy amongst patients randomised to virological monitoring whilst on first line compared with those monitored routinely using clinical and immunological monitoring.
  4. 4.To assess the incidence and outcome of tuberculosis (TB) and other opportunistic infections in patients treated at the Komfo Anokye Teaching Hospital HIV services
  5. 5.To obtain parameters for quality of care, e. g. performance of TB screening procedures
  6. 6.To develop strategies to minimise treatment failures, on the basis of the results of the study
  7. 7.To generate a large prospective second-line ART cohort, to serve as basis for further research projects
  8. 8.To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital
  9. 9.Capacity building: epidemiology, medical documentation and data base management. Enrollment of one PhD and one Master student

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

9.1 years

First QC Date

May 8, 2013

Last Update Submit

July 28, 2021

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • Clinical failure

    Combined endpoint is clinical failure 12 and 24 months after switch to second line treatment, defined as: 1. First/new AIDS defining event 2. Death

    12 and 24 months

Secondary Outcomes (1)

  • CD4 response

    12 and 24 months

Other Outcomes (4)

  • Frequency and time of therapy changes

    12 and 24 months

  • Loss-to-follow up

    12 and 24 months

  • ART-related Adverse Events (AE)

    12 and 24 months

  • +1 more other outcomes

Study Arms (2)

Virological monitoring

ACTIVE COMPARATOR

In addition to routine clinical and immunological monitoring with CD4 counts

Other: Virological monitoring

Routine monitoring

NO INTERVENTION

Immunological and clinical monitoring

Interventions

Virological monitoringOTHER
Virological monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able and willing to give informed written consent
  • age \> 18 years
  • on first line ART since \> 12 months

You may not qualify if:

  • not willing or able to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Location

Related Publications (2)

  • Keiser O, Tweya H, Braitstein P, Dabis F, MacPhail P, Boulle A, Nash D, Wood R, Luthi R, Brinkhof MW, Schechter M, Egger M; ART-LINC of IeDEA Study Group. Mortality after failure of antiretroviral therapy in sub-Saharan Africa. Trop Med Int Health. 2010 Feb;15(2):251-8. doi: 10.1111/j.1365-3156.2009.02445.x. Epub 2009 Dec 9.

    PMID: 20003034BACKGROUND

  • Seyler C, Adje-Toure C, Messou E, Dakoury-Dogbo N, Rouet F, Gabillard D, Nolan M, Toure S, Anglaret X. Impact of genotypic drug resistance mutations on clinical and immunological outcomes in HIV-infected adults on HAART in West Africa. AIDS. 2007 May 31;21(9):1157-64. doi: 10.1097/QAD.0b013e3281c615da.

    PMID: 17502726BACKGROUND

Study Officials

  • Fred S Sarfo, FWACP, PHD

    Kwame Nkrumah University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Kirsten A Eberhardt, Dr., MD

    Bernhard Nocht Institute for Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., MD

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 15, 2013

Study Start

June 1, 2012

Primary Completion

June 28, 2021

Study Completion

July 28, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

GH(1)