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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01905059
• Date of registration: 15/07/2013
• Prospective Registration: Yes
• Primary sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Public title: 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
• Scientific 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)
• Date of first enrolment: February 2014
• Target sample size: 265
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01905059
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Burkina Faso, Cameroon, Senegal

Contacts

• Name: Ndour Cheik Tidiane, Prof
• Affiliation: Service Maladies Infectieuses CHU Fann Dakar

• Name: Koulla Shiro Sinata, Prof
• Affiliation: University of Yaounde

• Name: Sawadogo Adrien, Dr
• Affiliation: Hopital de Jour CHU Bobo Dioulasso

• Name: Ciaffi Laura, Dr
• Affiliation: UMI 233 IRD Montpellier

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine

Drug: monoPI - boosted lopinavir or boosted darunavir

Primary Outcome(s)

Proportion of patients in virological failure [Time Frame: 96 weeks]

Secondary Outcome(s)

The Immune response [Time Frame: Between the inclusion and 96 weeks]

The viral resistance [Time Frame: 24 weeks from reintroduction NRTI regimen]

virological response [Time Frame: 96 weeks]

Assessment neurocognitive functions [Time Frame: 96 weeks]

Changes in anthropometric measures [Time Frame: between the inclusion and 96 weeks]

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

Treatment failure after reintroduction of the baseline NRTI backbone regimen [Time Frame: 24 weeks from reintroduction NRTI regimen]

The clinical course of the HIV infection [Time Frame: Inclusion to 96 weeks]

Tolerability [Time Frame: Between the inclusion and 96 weeks]

Virological response [Time Frame: 48 weeks]

Secondary ID(s)

ANRS 12286MOBIDIP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Pharmaceuticals