Trial record 8 of 32 for:    " July 10, 2013":" August 09, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa (MOBIDIP)

This study is not yet open for participant recruitment.
Verified February 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01905059
First received: July 15, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

Multicenter, randomized, superiority trial to evaluate efficacy of a mono or bi-therapy of protease inhibitors with or without lamivudine over a period of 96 weeks. The primary outcome will be the failure rate at 96 weeks. This study will include 260 participants, former participants of the 2LADY trial. It will be carried out in Yaoundé, Bobo Dioulasso and Dakar.


Condition Intervention Phase
HIV Infection
Drug: monoPI - boosted lopinavir or boosted darunavir
Drug: bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, International, Prospective, Phase III, Randomized, Superiority Trial Comparing Two Maintenance Strategies With Mono or Bi-therapy of Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment Over a Period of 96 Weeks in Africa (Dakar, Bobo Dioulasso, Yaounde)

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Proportion of patients in virological failure [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Number of patients with a treatment failure. Definition of treatment failure: 1) viral load ≥ 500 copies/ml confirmed in 2 samples with 1 month interval, or 2) the reintroduction of the two NRTIs or 3) interruption of the boosted PI.


Secondary Outcome Measures:
  • Treatment failure after reintroduction of the baseline NRTI backbone regimen [ Time Frame: 24 weeks from reintroduction NRTI regimen ] [ Designated as safety issue: No ]
    Number of patients in virological failure after reintroduction NRTI regimen. Treatment failure defined by viral load > 200 and/or > 500 copies/ml within 24 weeks from the reintroduction of the baseline NRTI backbone regimen

  • Virological response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Number of patient with VL < 50 copies/ml

  • The viral resistance [ Time Frame: 24 weeks from reintroduction NRTI regimen ] [ Designated as safety issue: No ]
    The frequency of resistance mutations in the case of treatment failure

  • The clinical course of the HIV infection [ Time Frame: Inclusion to 96 weeks ] [ Designated as safety issue: No ]
    Numbers of : AIDS events, non-AIDS events, death, adverse events

  • The Immune response [ Time Frame: Between the inclusion and 96 weeks ] [ Designated as safety issue: No ]
    The variation in the level of circulating CD4+ lymphocytes

  • Tolerability [ Time Frame: Between the inclusion and 96 weeks ] [ Designated as safety issue: Yes ]
    Changes to the parameters in baseline lipid profile, renal function and bone mineral density

  • Assessment of the adherence [ Time Frame: 96 weeks but an average of mesures of each visits ] [ Designated as safety issue: No ]

    Adherence is considered high if consumption is greater than or equal to 95%, average if it is between 80 and 95% and low if it is less than 80%.

    It is measured at each visit, by means of a questionnaire and by tablet count.


  • Changes in anthropometric measures [ Time Frame: between the inclusion and 96 weeks ] [ Designated as safety issue: Yes ]
    Changes to the following anthropometric measurements: waist circumference, hip circumference and thigh circumference

  • Assessment neurocognitive functions [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    screening questions (EACS Guidelines)

  • virological response [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Number of patient with VL < 50 copies/ml


Estimated Enrollment: 264
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: monoPI - boosted lopinavir or boosted darunavir
boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)
Drug: monoPI - boosted lopinavir or boosted darunavir
boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)
Other Names:
  • Protease Inhibitor monotherapy
  • boosted darunavir monotherapy
  • boosted lopinavir monotherapy
Active Comparator: bi therapy - (boosted lopinavir or darunavir) + lamivudine
boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) with lamivudine 300 mg QD or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)with lamivudine 300 mg QD
Drug: bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine
boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) with lamivudine 300 mg QD or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)with lamivudine 300 mg QD
Other Names:
  • bi therapy
  • PI + 3TC
  • Boosted Protease Inhibitors plus lamivudine
  • LPV/r with lamivudine and DRV/r with lamivudine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection on second line treatment in the 2lady trial for at least 48 weeks
  • VL ≤ 200 copies/ml since at least 6 months
  • No change in ART in the last 3 months previous to the study
  • CD4> 100 cells/ml
  • Signed informed consent
  • Adherence >90

Exclusion Criteria:

  • Previous viral failure (at least 2 consecutive HIV RNA >1000 copies/ml) while receiving a PI
  • Ongoing pregnancy and breast feeding women
  • HBsAg positive patients
  • opportunistic infection or any severe or progressive disease ongoing or treated in the 3 months before screening
  • Subject who in the investigator's opinion is unable to complete the study
  • History or symptoms of HIV encephalopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905059

Contacts
Contact: Ciaffi Laura, Dr 0033 467 41 62 97 laura.ciaffi@ird.fr

Locations
Burkina Faso
Day Care Center CHU Sanou Sauro Not yet recruiting
Bobo Dioulasso, Burkina Faso
Cameroon
Central Hospital Not yet recruiting
Yaounde, Cameroon
Military Hospital Not yet recruiting
Yaounde, Cameroon
Senegal
CRCF Hopital de Fann Not yet recruiting
Dakar, Senegal
CTA CHU de Fann Not yet recruiting
Dakar, Senegal
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Janssen Pharmaceuticals
Investigators
Principal Investigator: Koulla Shiro Sinata, Prof University of Yaounde
Principal Investigator: Sawadogo Adrien, Dr Hopital de Jour CHU Bobo Dioulasso
Principal Investigator: Ndour Cheik Tidiane, Prof Service Maladies Infectieuses CHU Fann Dakar
Principal Investigator: Ciaffi Laura, Dr UMI 233 IRD Montpellier
  More Information

Additional Information:
Publications:

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01905059     History of Changes
Other Study ID Numbers: ANRS 12286MOBIDIP
Study First Received: July 15, 2013
Last Updated: February 4, 2014
Health Authority: Cameroon: Health Operational Reserach Division, MOH Cameroon
Burkina Faso: Ministry of Health
Burkina Faso: Ministère de la recherche scientifique et de l'innovation
Burkina Faso: Comité d'Ethique pour la Recherche en Santé
Senegal: Ministere de la santé et de l'action sociale
Senegal: Comité National d'Ethique pour la Recherche en Santé
Senegal: Comité National de Lutte contre le SIDA

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV infection
second line ART
maintenance strategies
Protease inhibitors
mono or bi-therapy

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Lopinavir
Darunavir
HIV Protease Inhibitors
Lamivudine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014