Clinical trial NCT01737359: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Human Immunodeficiency Virus Infection
Keywords: amdoxovir
zidovudine
tenofovir DF
HIV
HAART
antiretroviral
Lead sponsor: RFS Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: HIV-1 viral load
timeFrame: change from baseline to Week 2
measure: Safety and Tolerability- Incidence of adverse events and laboratory abnormalities
timeFrame: number and frequency from baseline through Week 12
Secondary outcomes:
measure: HIV-1 viral load
timeFrame: change from baseline to Weeks 4, 8 and 12
measure: Changes in Immunologic Function (CD4 cell counts)
timeFrame: changes from baseline to Weeks 4, 8 and 12
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
Study officials:
affiliation: RFS Pharma
name: Luz Pascual, MD MPH
role: STUDY_DIRECTOR
References: