Human Immunodeficiency Virus InfectionPhase 2NCT01737359
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
A Phase 2 study testing amdoxovir 300 mg bid, amdoxovir 500 mg bid and tenofovir DF 300 mg qd in people with Human Immunodeficiency Virus Infection, run by RFS Pharma, LLC at 6 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- What is being tested?
- amdoxovir 300 mg bid, amdoxovir 500 mg bid and tenofovir DF 300 mg qd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 6 sitesArgentina
- Study dates
- Dec 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Argentina6 sites
Research Site
Buenos Aires, Buenos Aires, C1141ACG
Research Site
Buenos Aires, Buenos Aires, C1202ABB
Research Site
Buenos Aires, Buenos Aires, C1405CKC
Research Site
Buenos Aires, Buenos Aires, C1426EGR
Research Site
Rosario, Santa Fe Province, S2000CXP
Research Site
Rosario, Santa Fe Province, S2000PBJ
About this study
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.
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.
- Conditions
- Human Immunodeficiency Virus Infection
- Being tested
- amdoxovir 300 mg bid, amdoxovir 500 mg bid, tenofovir DF 300 mg qd
- Keywords
- amdoxovir, zidovudine, tenofovir DF, HIV, HAART, antiretroviral
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amdoxovir 300 mg bidDrug
Also called DAPD, AMDX
2 x 150 mg capsules bid
amdoxovir 500 mg bidDrug
Also called DAPD, AMDX
2 x 250 mg capsules bid
tenofovir DF 300 mg qdDrug
Also called Viread
1 x 300 mg tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| amdoxovir 300 mg bid | Experimental | in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3 Receives: Drug: amdoxovir 300 mg bid |
| amdoxovir 500 mg bid | Experimental | in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3 Receives: Drug: amdoxovir 500 mg bid |
| tenofovir DF 300 mg qd | Active comparator | in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3 Receives: Drug: tenofovir DF 300 mg qd |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 viral load
Measured: change from baseline to Week 2
Safety and Tolerability- Incidence of adverse events and laboratory abnormalities
Measured: number and frequency from baseline through Week 12
Secondary outcomes (2)
HIV-1 viral load
Measured: change from baseline to Weeks 4, 8 and 12
Changes in Immunologic Function (CD4 cell counts)
Measured: changes from baseline to Weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- RFS Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luz Pascual, MD MPH, Study director, RFS Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737359
- Sponsor's protocol ID
- RFSP-AMDX-2010
- Status last verified
- Mar 2013
- First submitted
- 27 Nov 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01737359
- Acronym / sponsor ID
- RFSP-AMDX-2010
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- amdoxovir, zidovudine, tenofovir DF, HIV, HAART, antiretroviral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- RFS Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amdoxovir 300 mg bid | Experimental | Drug: amdoxovir 300 mg bidin combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3 |
| amdoxovir 500 mg bid | Experimental | Drug: amdoxovir 500 mg bidin combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3 |
| tenofovir DF 300 mg qd | Active comparator | Drug: tenofovir DF 300 mg qdin combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amdoxovir 300 mg bidAlso: DAPD, AMDX2 x 150 mg capsules bid | Drug | amdoxovir 300 mg bid |
| amdoxovir 500 mg bidAlso: DAPD, AMDX2 x 250 mg capsules bid | Drug | amdoxovir 500 mg bid |
| tenofovir DF 300 mg qdAlso: Viread1 x 300 mg tablet once daily | Drug | tenofovir DF 300 mg qd |
Primary outcome
HIV-1 viral load
Time frame: change from baseline to Week 2
Safety and Tolerability- Incidence of adverse events and laboratory abnormalities
Time frame: number and frequency from baseline through Week 12
2 secondary outcomes
HIV-1 viral load
Time frame: change from baseline to Weeks 4, 8 and 12
Changes in Immunologic Function (CD4 cell counts)
Time frame: changes from baseline to Weeks 4, 8 and 12
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luz Pascual, MD MPH study director
RFS Pharma
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amdoxovir 300 mg bid, amdoxovir 500 mg bid and tenofovir DF 300 mg qd in people with Human Immunodeficiency Virus Infection, run by RFS Pharma, LLC at 6 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 viral load (time frame: change from baseline to Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.