SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00106379

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment

The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.

NCT00106379 HIV Infections
MeSH: HIV Infections

3 Interventions

Name: Truvada (tenofovir DF + emtricitabine)

Type: Drug

Name: Emtriva (emtricitabine)

Type: Drug

Name: Viread (tenofovir DF)

Type: Drug


Primary Outcomes

Measure: HIV-1 infection

Secondary Outcomes

Measure: HIV-1 infection in renally impaired HIV infected patients

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 K65R

- Women of childbearing potential who are unwilling to use an effective contraceptive method during the study - Contraindications to tenofovir DF, emtricitabine or efavirenz - Undergoing treatment for tuberculosis - Using atazanavir - Prior history of mutation M184V, K65R or T69 insertion - Z-score on pre-baseline DEXA scan less than -2.5 - The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm3. --- M184V --- --- K65R ---


2 M184V

- Women of childbearing potential who are unwilling to use an effective contraceptive method during the study - Contraindications to tenofovir DF, emtricitabine or efavirenz - Undergoing treatment for tuberculosis - Using atazanavir - Prior history of mutation M184V, K65R or T69 insertion - Z-score on pre-baseline DEXA scan less than -2.5 - The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm3. --- M184V ---



HPO Nodes