NCT02191202

Brief Summary

Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for all trials

Status
completed

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, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

July 15, 2014

Last Update Submit

July 15, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score

    Baseline, month 1, 6 and 12

Secondary Outcomes (12)

  • Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population

    Baseline, 12 months

  • Changes in symptom scale score

    Baseline, month 1, 6 and 12

  • Changes in Hospital Anxiety and Depression scale (HADS)

    Baseline, month 1, 6 and 12

  • Changes in cluster of differentiation 4 (CD4) cell count

    Baseline and month 3, 6, 9, 12

  • Changes in viral load

    Baseline and month 3, 6, 9, 12

  • +7 more secondary outcomes

Study Arms (1)

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Interventions

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)DRUG
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital physicians, specialized in treatment of patients infected by the HIV

You may qualify if:

  • NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load \< 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included
  • Patients must read and write French

You may not qualify if:

  • Patients in whom a new treatment is initiated because of treatment failure
  • new treatment does not comprise an NNRTI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 16, 2014

Study Start

June 1, 2004

Primary Completion

February 1, 2006

Last Updated

July 16, 2014

Record last verified: 2014-07