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Report for Clinical Trial NCT02247687

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

Management of participants with low-level persistent viremia

NCT02247687 HIV-1 Infection Treatment Resistant Disorders Viremia
MeSH:Viremia

3 Interventions

Name: Protease inhibitor

Description: Modification in the antiretroviral treatment •Switch arm for protease inhibitor : intervention switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
Type: Drug
Group Labels: 1

Switch arm for protease inhibitor

Name: Isentress® (raltegravir)

Description: • Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Type: Drug
Group Labels: 1

Addition of Isentress® (raltegravir)

Name: Counseling arm

Description: No change of antiretroviral treatment but only counseling
Type: Other
Group Labels: 1

Counseling arm


Primary Outcomes

Description: A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12.

Measure: Proportion of patients in Virologic success by week 12

Time: week 12

Secondary Outcomes

Measure: Proportion of participants with HIV-1 RNA < 50 copies/ml

Time: week 4, week 8, week 12, week 24, week 36, week 48

Measure: Proportion of participants with HIV-1 RNA < 20 copies/ml

Time: week 4, week 8, week 12, week 24, week 36, week 48

Measure: Proportion of participants with HIV-1 RNA <1copy/ml

Time: week 8, week 12, week 24, week 36, week 48

Description: •Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count

Measure: Change in CD4 cells count from baseline

Time: week 12, week 24, week 48 and end visit

Description: •resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA

Measure: Number of Participants With Virologic Failure and Emergence of Resistance

Time: day 0 and visit at failure time

Description: Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm

Measure: Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC)

Time: day 0

Description: •plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy

Measure: Levels of antiretroviral drugs in plasma

Time: day 0 and end visit

Description: •measurement of concentrations of antiretroviral drugs treatments in hair

Measure: Levels of antiretroviral drugs in hair

Time: day 0, week 12, week 24and end visit

Description: quantification of HIV RNA in seminal plasma

Measure: Levels of HIV-1 RNA in seminal plasma

Time: day 0, week 12, week 48 and end visit

Description: •proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure

Measure: Incidence of Study interruption

Time: From day 0 to week 24

Description: • proportions of participants experiencing a clinical or biological adverse events (ANRS scale)

Measure: Incidence of clinical and biological adverse events

Time: from day 0 to week 48

Description: •self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks

Measure: Self-reported adherence

Time: day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

- Participant naïve to raltegravir (RAL) - failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation) - creatinin < 3 Upper Limit normal (ULN) - Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN) - hemoglobin > 8 g/dL - platelets > 50 000/mm3 - In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method - Informed consent - Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique) Exclusion Criteria: - HIV-2 infection, - severe medical condition in the last month (inclusion is possible for a stable condition at screening) - breastfeeding women, current pregnancy or planned pregnancy within 12 months. --- M184V ---



HPO Nodes