SNPMiner Trials by Shray Alag

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Report for Mutation A98S

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials

1 A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol

The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.

NCT02527096 HIV-1 Infection Drug: dolutegravir (Tivicay®) - Phase 1 Drug: lamivudine (Epivir®) - Phase 2 Drug: dolutegravir (Tivicay®) - Phase 2
MeSH:Acquired Immunodeficiency Syndrome HIV Infections

Inclusion Criteria: - HIV-1 infected patient - Age ≥ 18 years - CD4 cell count nadir > 200/mm3 - Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance group's algorithm which presents: - no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, 154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the mutation A98S if the patient is not infected by the virus subtype C), - no mutation on integrase (if the genotype is available), - First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or 1 INI). --- D30N --- --- V32I --- --- M46I --- --- I47A --- --- G48V --- --- I50L --- --- L76V --- --- V82A --- --- I84V --- --- N88D --- --- L90M --- --- A98S ---

Primary Outcomes

Description: Virological failure is defined by plasma HIV RNA > 50 cp/mL on 2 following samples at 2 to 4 weeks apart.

Measure: Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis)

Time: from week 8 to week 56 (± 4 weeks)

Secondary Outcomes

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

Measure: Evolution of CD4 and CD8 lymphocytes count (analysis)

Time: from week 8 to week 32 and week 56

Measure: Percentage of participants who discontinued the strategy of the trial for toxicity or with adverse event of grade 3 or 4 (analysis)

Time: week 56

Measure: Profile of resistance mutations in plasma in case of virological failure

Time: week 56

Measure: Percentage of participants with plasma HIV RNA < 1 cp/mL

Time: Day 0, week 8, week 32 and week 56

Description: Influence of total DNA at Day 0 on the occurrence of virological failure or blip

Measure: Influence of total DNA on the occurrence of virological failure or blip

Time: from Day 0 to week 56

Measure: Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip

Time: week 56

Measure: Measure of adherence to treatment (self-reported)

Time: Day 0, week 4, week 8, week 32 and week 56

Measure: Measure of quality of life (self-reported)

Time: Day 0, week 8 and week 56

Description: Evaluation of medico-economic aspects. Evaluate the direct medical cost related to dolutegravir and lamivudine versus the cost of the previous treatment.

Measure: Comparison of Medico-economic substudy (analysis)

Time: week 56

Description: Measure of concentrations of dolutegravir and NRTI, and HIV RNA in semen at Week 8 and Week 32 in a subgroup of 20 participants

Measure: Sperm substudy measure of concentration

Time: Week 8 and week 32

HPO Nodes