SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03160105

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial

The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.

NCT03160105 HIV-1-infection Antiretroviral Therapy Maintenance Therapy
MeSH: Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome

2 Interventions

Name: Switch to DTG + FTC

Description: Switch from standard cART to DTG + FTC dual maintenance therapy.

Type: Drug

Switch to DTG+FTC + Standard monitoring Switch to DTG+FTC + Patient-centered monitoring

Name: Patient-centered monitoring

Description: Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36

Type: Other

Continuing cART + Patient-centered monitoring Switch to DTG+FTC + Patient-centered monitoring


Primary Outcomes

Description: Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks

Measure: Efficacy of DTG-based maintenance therapy (< 100 copies/ml)

Time: 48 weeks

Description: Direct costs of the two study arms from the health care system perspective at week 48

Measure: Costs of a patient-centered ART monitoring

Time: 48 weeks

Secondary Outcomes

Description: Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks

Measure: Efficacy of DTG-based maintenance therapy (<50 copies/ml)

Time: 48 weeks

Description: Proportion of patients with HIV-RNA < 50 cp/ml at week 48

Measure: Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis

Time: 48 weeks

Description: defined as the first of the two-confirmed HIV-RNA >100 copies/ml (at least two weeks apart)

Measure: HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR)

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in CD4 cell count

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in HIV-DNA

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in lipidic profile

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in glucose profile

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in Framingham-calculated cardiovascular risk

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in glomerular function rate

Time: 48 weeks

Description: throughout week 48

Measure: Proportion of patients with an adverse event

Time: 48 weeks

Description: throughout week 48

Measure: Proportion of patients with a severe adverse event

Time: 48 weeks

Description: throughout week 48

Measure: Proportion of patients with CNS adverse event

Time: 48 weeks

Description: at 2 and 6 week

Measure: Proportion of patients new to DTG with CNS symptoms

Time: 6 weeks

Description: from baseline to weeks 12 and 48

Measure: PROQOL questionnaire

Time: 48 weeks

Description: from baseline to weeks 24 and 48

Measure: Patient's monitoring satisfaction for pts in the patient-centered monitoring arm

Time: 48 weeks

Description: at week 48

Measure: Global satisfaction of the monitoring

Time: 48 weeks

Description: Monitoring satisfaction throughout 48 weeks

Measure: Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options

Time: 48 weeks

Description: at week 48

Measure: Patient's treatment satisfaction at week 48

Time: 48 weeks

Description: ART decided to be used in the post study period

Measure: ARV treatment in the post study

Time: 48 weeks

Description: at week 48

Measure: Study satisfaction

Time: 48 weeks

Description: at week 48

Measure: Cost-effectiveness of study arms

Time: 48 weeks

Description: from baseline to week 48

Measure: Change in patient weight

Time: 48 weeks

Description: Patient adherence to treatment throughout 48 weeks of follow-up

Measure: Adherence questions

Time: 48 weeks

Description: performed outside trial scheduled throughout 48 weeks

Measure: Number of study-related extra clinical visits

Time: 48 weeks

Purpose: Treatment

Allocation: Randomized

Factorial Assignment


There is one SNP

SNPs


1 M184V

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. --- M184V ---



HPO Nodes