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Report for Clinical Trial NCT01738555

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-label, 36-week Extension Study on Amdoxovir at 500 mg Bid or 300 mg Bid in Combination With Zidovudine and Lopinavir/Ritonavir in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.

This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.

NCT01738555 Human Immunodeficiency Virus Infection
MeSH:Acquired Immunodeficiency Syndrome HIV Infections

2 Interventions

Name: amdoxovir 300 mg bid

Description: 2 x 150 mg capsules bid
Type: Drug
Group Labels: 1

amdoxovir 300 mg bid

Name: amdoxovir 500 mg bid

Description: 2 x 250 mg capsules bid
Type: Drug
Group Labels: 1

amdoxovir 500 mg bid


Primary Outcomes

Measure: HIV-1 viral load

Time: up to 48 Weeks

Secondary Outcomes

Measure: Incidence of adverse events

Time: up to 48 Weeks

Measure: Changes in Immunologic Function (CD4 cell counts)

Time: from baseline to Weeks 18, 24, 30, 36, 42, 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184I

An Open-label, 36-week Extension Study on Amdoxovir at 500 mg Bid or 300 mg Bid in Combination With Zidovudine and Lopinavir/Ritonavir in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.. --- M184I ---



HPO Nodes