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Report for Clinical Trial NCT00344461

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir

Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used.

NCT00344461 HIV

1 Interventions

Name: Nevirapine, FTC, and Tenofovir

Description: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
Type: Drug
Group Labels: 1

Nevirapine, FTC, Tenofovir


Primary Outcomes

Description: The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.

Measure: Number of Participants With Sustained Virologic Response

Time: 96 Weeks

Secondary Outcomes

Description: The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.

Measure: Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities

Time: Protocol length is 96 weeks

Description: The number of participants with plasma HIV RNA < 50 copies/mL

Measure: Patients With Plasma HIV RNA < 50 Copies/mL

Time: 96 weeks.

Description: The number of participants with plasma HIV RNA < 400 copies/mL

Measure: Patients With Plasma HIV RNA < 400 Copies/mL

Time: 96 weeks

Description: Percent Change From Baseline in Plasma HIV RNA at 96 weeks

Measure: Change in Plasma HIV RNA From Baseline to Week 96

Time: Baseline to week 96

Description: To determine the mean change from Baseline in CD4 cell count to week 96.

Measure: Changes in CD4 Cell Count From Baseline and Week 96

Time: Baseline to week 96

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 8 SNPs

SNPs


1 G190S

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C --- --- Y188L --- --- G190S ---


2 K103N

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N ---


3 K65R

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C --- --- Y188L --- --- G190S --- --- M41L --- --- Q151M --- --- L210W --- --- K65R ---


4 L210W

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C --- --- Y188L --- --- G190S --- --- M41L --- --- Q151M --- --- L210W ---


5 M41L

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C --- --- Y188L --- --- G190S --- --- M41L ---


6 Q151M

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C --- --- Y188L --- --- G190S --- --- M41L --- --- Q151M ---


7 Y181C

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C ---


8 Y188L

Evidence of mutation associated with primary drug resistance to Nevirapine (K103N, Y181C, Y188L, G190S), Tenofovir (M41L, T69 insertion, Q151M, L210W,and K65R), and/or FTC (184V) previously documented, or at time of screening. --- K103N --- --- Y181C --- --- Y188L ---



HPO Nodes