Last updated: 11/03/2018 20:37:32

SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS OF EFFICACY AND SAFETY/TOLERABILITY OF 3RD AGENT ANTIRETROVIRAL TREATMENTS IN ANTIRETROVIRAL-NAÏVE HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 POSITIVE PATIENTS

GSK study ID
200116
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS OF EFFICACY AND SAFETY/TOLERABILITY OF 3RD AGENT ANTIRETROVIRAL TREATMENTS IN ANTIRETROVIRAL-NAÏVE HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 POSITIVE PATIENTS
Trial description: To compare treatment efficacy and safety of guideline-recommended and newly-approved 3rd agents in treatment-naive HIV-1-infected individuals
To assess the impact of patient demographic and clinical covariates on treatment efficacy and safety of 3rd agents in treatment-naïve HIV-1-infected individuals
To identify and collect data on treatment efficacy and safety of guideline-recommended and newly-approved 3rd agents in treatment-experienced HIV-1-infected individuals for use in future data analyses
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of patients with virologic suppression at 12/24/48/96 weeks of treatment

Timeframe: N/A

Secondary outcomes:

Number (percent) of treatment withdrawals related to adverse events (AEs) at Week 48/96

Timeframe: N/A

Interventions:
  • Drug: Boosted protease inhibitors
  • Drug: Integrase inhibitors
  • Drug: NNRTIs
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infection, Human Immunodeficiency Virus
    Product
    dolutegravir
    Collaborators
    Not applicable
    Study date(s)
    January 2013 to September 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    13 - 120 Year
    Accepts healthy volunteers
    none
    • Full text publications
    • Conference abstracts
    • Non-randomized observational studies
    • Phase 1 or 2 clinical trial
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Full text publications
    • Conference abstracts
    • English language
    • Patients ≥13 years
    • Phase 3, randomized clinical trials
    • Minimum trial duration of 12 weeks
    • Include single 3rd-agent regimens of interest (see section 2.3) in combination with an NRTI backbone with at least one comparator (i.e., not single arm studies)
    • Report one or more of the required efficacy/safety end-points
    • Wholly ART-naïve or -experienced population, or present data as subgroup analyses
    • Patients with HIV-1 infection only
    Exclusion criteria:
    • Non-randomized observational studies
    • Phase 1 or 2 clinical trial
    • Studies/data focusing on patients <13 years of age
    • Single arm studies or studies examining different dosages of the same drug
    • Treatment arm which exams treatment no longer recommended (e.g., delavirdine, unboosted PIs)
    • Sample size N<50 for each treatment arm

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-23-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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