SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT00525733

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects

The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.

NCT00525733 HIV Infections
MeSH: Infection HIV Infections

5 Interventions

Name: darunavir 800 mg

Description: darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

Type: Drug

3-drug standard therapy 5-drug experimental therapy

Name: FTC 200 mg/TDF 300mg

Description: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

Type: Drug

3-drug standard therapy 5-drug experimental therapy

Name: Maraviroc

Description: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)

Type: Drug

5-drug experimental therapy

Name: Raltegravir

Description: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)

Type: Drug

5-drug experimental therapy

Name: Ritonavir 100 mg

Description: one tablet of ritonavir is taken with darunavir daily

Type: Drug

3-drug standard therapy 5-drug experimental therapy


Primary Outcomes

Measure: The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.

Time: 48 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 6 SNPs

SNPs


1 I50L

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L ---


2 I84V

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L --- --- I84V ---


3 K65R

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R ---


4 M184V

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V ---


5 N88S

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L --- --- I84V --- --- N88S ---


6 Q151M

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M ---



HPO Nodes