Human Immunodeficiency Virus InfectionPhase 2NCT01738555
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects
A Phase 2 study testing amdoxovir 300 mg bid and amdoxovir 500 mg bid in people with Human Immunodeficiency Virus Infection, run by RFS Pharma, LLC.
Trial summary
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. 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 and amdoxovir 500 mg bid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Oct 2014
- 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
- Must have completed Study RFSP-AMDX-2010 and received treatment with amdoxovir (500 mg bid or 300 mg bid) for 12 weeks before entry into study RFSP-AMDX-2012.
- Must have maintained ≥ 1.0 log10 copies/mL from baseline at Week 12 in Study RFSP-AMDX-2010.
- Must not have had any serious adverse experience since enrollment in Study RFSP-AMDX-2010, whether or not considered to be study drug-related.
Who cannot join
- Subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal excretion.
- Subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic agents.
- Subjects who require medications that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with life-threatening adverse events.
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
- Women who are pregnant or breastfeeding.
About this study
Official title: 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.
- Conditions
- Human Immunodeficiency Virus Infection
- Being tested
- amdoxovir 300 mg bid, amdoxovir 500 mg bid
- Keywords
- amdoxovir, zidovudine, 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
| Study group | Role | What they receive |
|---|---|---|
| amdoxovir 300 mg bid | Experimental | in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks. Receives: Drug: amdoxovir 300 mg bid |
| amdoxovir 500 mg bid | Experimental | in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks. Receives: Drug: amdoxovir 500 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 viral load
Measured: up to 48 Weeks
Secondary outcomes (2)
Incidence of adverse events
Measured: up to 48 Weeks
Changes in Immunologic Function (CD4 cell counts)
Measured: from baseline to Weeks 18, 24, 30, 36, 42, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionAug 2014 (estimated)
- Study completionOct 2014 (estimated)
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
- None (open label)
- Enrolment
- 0 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, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738555
- Sponsor's protocol ID
- RFSP-AMDX-2012
- Status last verified
- Mar 2013
- First submitted
- 28 Nov 2012
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01738555
- Acronym / sponsor ID
- RFSP-AMDX-2012
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- amdoxovir, zidovudine, HIV, HAART, antiretroviral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RFS Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 30 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amdoxovir 300 mg bid | Experimental | Drug: amdoxovir 300 mg bidin combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks. |
| amdoxovir 500 mg bid | Experimental | Drug: amdoxovir 500 mg bidin combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have completed Study RFSP-AMDX-2010 and received treatment with amdoxovir (500 mg bid or 300 mg bid) for 12 weeks before entry into study RFSP-AMDX-2012.
- Must have maintained ≥ 1.0 log10 copies/mL from baseline at Week 12 in Study RFSP-AMDX-2010.
- Must not have had any serious adverse experience since enrollment in Study RFSP-AMDX-2010, whether or not considered to be study drug-related.
Key exclusion criteria (5 listed)
- Subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal excretion.
- Subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic agents.
- Subjects who require medications that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with life-threatening adverse events.
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
- Women who are pregnant or breastfeeding.
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 |
Primary outcome
HIV-1 viral load
Time frame: up to 48 Weeks
2 secondary outcomes
Incidence of adverse events
Time frame: up to 48 Weeks
Changes in Immunologic Function (CD4 cell counts)
Time frame: from baseline to Weeks 18, 24, 30, 36, 42, 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amdoxovir 300 mg bid and amdoxovir 500 mg bid in people with Human Immunodeficiency Virus Infection, run by RFS Pharma, LLC.
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: withdrawn, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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: up to 48 Weeks). 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 29 Mar 2013.