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)
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ClinicalTrials.gov Identifier: NCT01905059 |
Recruitment Status
:
Completed
First Posted
: July 23, 2013
Last Update Posted
: July 21, 2017
|
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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 |

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 |

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:
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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:
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- 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.
- 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
- Virological response [ Time Frame: 48 weeks ]Number of patient with VL < 50 copies/ml
- The viral resistance [ Time Frame: 24 weeks from reintroduction NRTI regimen ]The frequency of resistance mutations in the case of treatment failure
- The clinical course of the HIV infection [ Time Frame: Inclusion to 96 weeks ]Numbers of : AIDS events, non-AIDS events, death, adverse events
- The Immune response [ Time Frame: Between the inclusion and 96 weeks ]The variation in the level of circulating CD4+ lymphocytes
- Tolerability [ Time Frame: Between the inclusion and 96 weeks ]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 ]
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 ]Changes to the following anthropometric measurements: waist circumference, hip circumference and thigh circumference
- Assessment neurocognitive functions [ Time Frame: 96 weeks ]screening questions (EACS Guidelines)
- virological response [ Time Frame: 96 weeks ]Number of patient with VL < 50 copies/ml

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Additional Information:
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 |