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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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amdoxovir 300 mg bid

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

Group Type EXPERIMENTAL

amdoxovir 300 mg bid

Intervention Type DRUG

2 x 150 mg capsules bid

amdoxovir 500 mg bid

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

Group Type EXPERIMENTAL

amdoxovir 500 mg bid

Intervention Type DRUG

2 x 250 mg capsules bid

tenofovir DF 300 mg qd

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

Group Type ACTIVE_COMPARATOR

tenofovir DF 300 mg qd

Intervention Type DRUG

1 x 300 mg tablet once daily

Interventions

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amdoxovir 300 mg bid

2 x 150 mg capsules bid

Intervention Type DRUG

amdoxovir 500 mg bid

2 x 250 mg capsules bid

Intervention Type DRUG

tenofovir DF 300 mg qd

1 x 300 mg tablet once daily

Intervention Type DRUG

Other Intervention Names

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DAPD AMDX DAPD AMDX Viread

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No