ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01905059
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : July 21, 2017
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)

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Drug: monoPI - boosted lopinavir or boosted darunavir Drug: bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine Phase 3

  Show Detailed Description

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : February 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)

This arm has been stopped on advise of DSMB (approved by Scientific Committee), patients are switched to standard second line triple therapy and followed until the end of the study at week 96.

 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) This arm was stopped by the Scientific Committee on advise of the DSMB after interim analysis showing increased risk of failure for these participants. Participants are switched to standard second line triple therapy and will be followed until the last visit at week 96.
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. This arm is going on, patients will be followed on this intervention until the end of the study at week 96
Other Names:
  • bi therapy
  • PI + 3TC
  • Boosted Protease Inhibitors plus lamivudine
  • LPV/r with lamivudine and DRV/r with lamivudine


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of patients in virological failure [ Time Frame: 96 weeks ]
    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 :
  1. Treatment failure after reintroduction of the baseline NRTI backbone regimen [ Time Frame: 24 weeks from reintroduction NRTI regimen ]
    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

  2. Virological response [ Time Frame: 48 weeks ]
    Number of patient with VL < 50 copies/ml

  3. The viral resistance [ Time Frame: 24 weeks from reintroduction NRTI regimen ]
    The frequency of resistance mutations in the case of treatment failure

  4. The clinical course of the HIV infection [ Time Frame: Inclusion to 96 weeks ]
    Numbers of : AIDS events, non-AIDS events, death, adverse events

  5. The Immune response [ Time Frame: Between the inclusion and 96 weeks ]
    The variation in the level of circulating CD4+ lymphocytes

  6. Tolerability [ Time Frame: Between the inclusion and 96 weeks ]
    Changes to the parameters in baseline lipid profile, renal function and bone mineral density

  7. Assessment of the adherence [ Time Frame: 96 weeks but an average of mesures of each visits ]

    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.


  8. Changes in anthropometric measures [ Time Frame: between the inclusion and 96 weeks ]
    Changes to the following anthropometric measurements: waist circumference, hip circumference and thigh circumference

  9. Assessment neurocognitive functions [ Time Frame: 96 weeks ]
    screening questions (EACS Guidelines)

  10. virological response [ Time Frame: 96 weeks ]
    Number of patient with VL < 50 copies/ml


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905059


Locations
Burkina Faso
Day Care Center CHU Sanou Sauro
Bobo Dioulasso, Burkina Faso
Cameroon
Central Hospital
Yaounde, Cameroon
Military Hospital
Yaounde, Cameroon
Senegal
CRCF Hopital de Fann
Dakar, Senegal
CTA CHU de Fann
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Sponsor site  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Lopinavir
Darunavir
 HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors