SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01737359

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.

This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily. The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.

NCT01737359 Human Immunodeficiency Virus Infection
MeSH: Acquired Immunodeficiency Syndrome HIV Infections Virus Diseases

3 Interventions

Name: amdoxovir 300 mg bid

Description: 2 x 150 mg capsules bid

Type: Drug

amdoxovir 300 mg bid

Name: amdoxovir 500 mg bid

Description: 2 x 250 mg capsules bid

Type: Drug

amdoxovir 500 mg bid

Name: tenofovir DF 300 mg qd

Description: 1 x 300 mg tablet once daily

Type: Drug

tenofovir DF 300 mg qd


Primary Outcomes

Measure: HIV-1 viral load

Time: change from baseline to Week 2

Measure: Safety and Tolerability- Incidence of adverse events and laboratory abnormalities

Time: number and frequency from baseline through Week 12

Secondary Outcomes

Measure: HIV-1 viral load

Time: change from baseline to Weeks 4, 8 and 12

Measure: Changes in Immunologic Function (CD4 cell counts)

Time: changes from baseline to Weeks 4, 8 and 12

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 4 SNPs

SNPs


1 K65R

- Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. --- K65R ---


2 L74V

- Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. --- K65R --- --- L74V ---


3 M184I

A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.. --- M184I ---

- Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening. --- M184I ---


4 Q151M

- Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. --- K65R --- --- L74V --- --- Q151M ---



HPO Nodes