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A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.

Primary Purpose

Human Immunodeficiency Virus Infection

Status

Terminated

Phase

Phase 2

Locations

Argentina

Study Type

Interventional

Intervention

amdoxovir 300 mg bid

amdoxovir 500 mg bid

tenofovir DF 300 mg qd

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Infection focused on measuring amdoxovir, zidovudine, tenofovir DF, HIV, HAART, antiretroviral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female ≥ 18 years old with HIV-1 RNA ≥ 2,000 copies/mL and currently failing therapy.
Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening.
Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy.

Exclusion Criteria:

Current or recent (last 30 days of study entry) AIDS defining diseases.
Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation.
Prior exposure to lopinavir/ritonavir or amdoxovir.
Impaired hepatic function (ALT > 5 x ULN).
Women who are pregnant or breast feeding.

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

amdoxovir 300 mg bid

amdoxovir 500 mg bid

tenofovir DF 300 mg qd

Arm Description

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Outcomes

Primary Outcome Measures

HIV-1 viral load

Safety and Tolerability- Incidence of adverse events and laboratory abnormalities

Secondary Outcome Measures

HIV-1 viral load

Changes in Immunologic Function (CD4 cell counts)

Full Information

NCT ID

NCT01737359

First Posted

November 27, 2012

Last Updated

November 4, 2014

Sponsor

RFS Pharma, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01737359

Brief Title

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Study Start Date

December 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RFS Pharma, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus Infection

Keywords

amdoxovir, zidovudine, tenofovir DF, HIV, HAART, antiretroviral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

amdoxovir 300 mg bid

Arm Type

Experimental

Arm Description

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Arm Title

amdoxovir 500 mg bid

Arm Type

Experimental

Arm Description

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Arm Title

tenofovir DF 300 mg qd

Arm Type

Active Comparator

Arm Description

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Intervention Type

Drug

Intervention Name(s)

amdoxovir 300 mg bid

Other Intervention Name(s)

DAPD, AMDX

Intervention Description

2 x 150 mg capsules bid

Intervention Type

Drug

Intervention Name(s)

amdoxovir 500 mg bid

Other Intervention Name(s)

DAPD, AMDX

Intervention Description

2 x 250 mg capsules bid

Intervention Type

Drug

Intervention Name(s)

tenofovir DF 300 mg qd

Other Intervention Name(s)

Viread

Intervention Description

1 x 300 mg tablet once daily

Primary Outcome Measure Information:

Title

HIV-1 viral load

Time Frame

change from baseline to Week 2

Title

Safety and Tolerability- Incidence of adverse events and laboratory abnormalities

Time Frame

number and frequency from baseline through Week 12

Secondary Outcome Measure Information:

Title

HIV-1 viral load

Time Frame

change from baseline to Weeks 4, 8 and 12

Title

Changes in Immunologic Function (CD4 cell counts)

Time Frame

changes from baseline to Weeks 4, 8 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥ 18 years old with HIV-1 RNA ≥ 2,000 copies/mL and currently failing therapy. Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening. Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy. Exclusion Criteria: Current or recent (last 30 days of study entry) AIDS defining diseases. Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. Prior exposure to lopinavir/ritonavir or amdoxovir. Impaired hepatic function (ALT > 5 x ULN). Women who are pregnant or breast feeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luz Pascual, MD MPH

Organizational Affiliation

RFS Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000CXP

Country

Argentina

Facility Name

Research Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000PBJ

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1141ACG

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1202ABB

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1405CKC

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1426EGR

Country

Argentina

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.

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