Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03160105
• Date of registration: 16/05/2017
• Prospective Registration: Yes
• Primary sponsor: Calmy Alexandra
• Public title: Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV) Simpl'HIV
• Scientific title: Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial
• Date of first enrolment: May 19, 2017
• Target sample size: 186
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03160105
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Switzerland

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Informed consent as documented by signature;

2. Documented HIV-1 infection;

3. Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor
of the SHCS network;

4. = 18 years of age;

5. HIV-RNA <50 copies/mL at screening and for at least 24 weeks before screening on
effective suppressive cART, one blip with less than 200 copies/mL being allowed during
this period if followed by at least 2 results < 50 copies/mL.

6. On standard cART at the time of inclusion, i.e.:

- 2 NRTIs + either 1 NNRTI, 1 boosted PI or 1 INSTI;

- NRTI-sparing triple ARV regimen (e.g. 1 NRTI + 1 NNRTI + 1 InSTI);

- Dual therapy with protease inhibitor.

Exclusion Criteria:

1. HIV-2 infection;

2. Previous ART change for unsatisfactory virological response, i.e. slow initial
virological suppression, incomplete suppression or rebound. Change of drug or drug
class for convenience or toxic effect prevention or management is allowed.

Note: patients with documented genotype(s) presenting only a M184V mutation remain
eligible;

3. Creatinine clearance < 50ml/min;

4. ASAT or ALAT >2.5x upper limit of the norm;

5. Known hypersensitivity, intolerance or allergy to DTG or FTC;

6. Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses >
1x/week) to current treatment in the last 6 months;

7. Concomitant use of drugs that decrease DTG blood concentrations including
carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and
rifampicin;

8. Women who are pregnant or breast-feeding;

9. a. Presence of any INSTI-resistance. Non-availability of INSTI resistance testing is
NOT an exclusion criteria.

b. Non availability of previous routine resistance test, at least for reverse
transcriptase and protease genes.

Note: Subjects remain eligible in the absence of any previous resistance test only if
they are on their first-line antiretroviral regimen;

10. Evidence of acute or chronic hepatitis B virus infection based on results of serology
testing.



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

Health Condition(s) or Problem(s) studied

Antiretroviral Therapy

HIV-1-infection

Maintenance Therapy

Intervention(s)

Drug: Switch to DTG + FTC

Other: Patient-centered monitoring

Primary Outcome(s)

Efficacy of DTG-based maintenance therapy (< 100 copies/ml) [Time Frame: 48 weeks]

Costs of a patient-centered ART monitoring [Time Frame: 48 weeks]

Secondary Outcome(s)

Change in lipidic profile [Time Frame: 48 weeks]

ARV treatment in the post study [Time Frame: 48 weeks]

Cost-effectiveness of study arms [Time Frame: 48 weeks]

Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis [Time Frame: 48 weeks]

PROQOL questionnaire [Time Frame: 48 weeks]

Patient's monitoring satisfaction for pts in the patient-centered monitoring arm [Time Frame: 48 weeks]

Proportion of patients new to DTG with CNS symptoms [Time Frame: 6 weeks]

Adherence questions [Time Frame: 48 weeks]

Change in glucose profile [Time Frame: 48 weeks]

Proportion of patients with a severe adverse event [Time Frame: 48 weeks]

Proportion of patients with an adverse event [Time Frame: 48 weeks]

Change in glomerular function rate [Time Frame: 48 weeks]

Change in HIV-DNA [Time Frame: 48 weeks]

Change in CD4 cell count [Time Frame: 48 weeks]

Change in Framingham-calculated cardiovascular risk [Time Frame: 48 weeks]

Change in patient weight [Time Frame: 48 weeks]

Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options [Time Frame: 48 weeks]

Study satisfaction [Time Frame: 48 weeks]

Efficacy of DTG-based maintenance therapy (<50 copies/ml) [Time Frame: 48 weeks]

Global satisfaction of the monitoring [Time Frame: 48 weeks]

Patient's treatment satisfaction at week 48 [Time Frame: 48 weeks]

Proportion of patients with CNS adverse event [Time Frame: 48 weeks]

HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR) [Time Frame: 48 weeks]

Number of study-related extra clinical visits [Time Frame: 48 weeks]

Secondary ID(s)

CCER 2016-02210

Source(s) of Monetary Support

Please refer to primary and secondary sponsors