HiV1- PositivePhase 4EPZSwitchNCT01608269
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy
A Phase 4 study testing Abacavir/Lamivudine in people with HiV1- Positive, run by Therapeutic Concepts at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HiV1- Positive
- What is being tested?
- Abacavir/Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 RNA ≤ 50 copies/mL by HIV-1 Ultrasensitive RNA, Quantitative.
- Treatment experienced subjects on virologically stable HAART regimen containing tenofovir-emtricitabine or tenofovir-lamivudine.
- Subject with CD4 cells that do not increase by 15% and/or that decrease by 15% over previous 12 months period.
- -≥ 18 years of age
- Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
- Less than 7 days of prior ART with any licensed or investigational compound
Show all 16Show fewer
- Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix C) within 30 days of screening
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
- A female is eligible to enter and participate in this study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal) or
- Child-bearing potential, has a negative serum pregnancy test at screen, and agrees to one of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for at least 2 weeks after completion or premature discontinuation from the study to account for elimination of the investigational drug. Should a patient decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the birth control methods listed below:
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion)
- Sterilization (female patient or male partner of female patient)
- Any other methods with published data showing that the lowest expected failure rate for that method is <1% per year.
Who cannot join
- Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
- Patient who are HLA B5701 Positive
- Patient who are determined to have ≥2 thymidine analog mutations to RT
- History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.
- Patient is either pregnant at time of screening evaluation or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.
Read the detailed description
Utilizing the ABC/3TC FDC tablets as the NRTI backbone, this open label study will compare the safety and efficacy of ABC/3TC when used as replacement for subjects with suboptimal CD4- cells count who are receiving TDF/FTC. TYhis study will be conducted for 48 weeks in HIV infected, HLA*B5701 begative subjects who were initially suppressed on a HAART regiment that includes TDF/FTC QD.
- Conditions
- HiV1- Positive
- Being tested
- Abacavir/Lamivudine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir/LamivudineDrug
Also called ABC/3TC
one tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| ABC/3TC (Epzicom), NRTI | Other | Not described Receives: Drug: Abacavir/Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy.
Proportion of patients with CD4 changes from baseline at week 24 and 48. Proportion of patients with plasma HIV-1 RNA <75 copies/mL at week 24 and 48
Measured: 1 years
Secondary outcomes (1)
Safety
Adverse events and treatment limiting toxicities at all time points.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HiV1- PositiveStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therapeutic Concepts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608269
- Sponsor's protocol ID
- 101-002
- Acronym
- EPZSwitch
- Status last verified
- May 2012
- First submitted
- 25 May 2012
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy
- ClinicalTrials.gov ID
- NCT01608269
- Acronym / sponsor ID
- EPZSwitch / 101-002
- Conditions
- HiV1- Positive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Therapeutic ConceptsUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 May 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.
The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.
Detailed description
Utilizing the ABC/3TC FDC tablets as the NRTI backbone, this open label study will compare the safety and efficacy of ABC/3TC when used as replacement for subjects with suboptimal CD4- cells count who are receiving TDF/FTC. TYhis study will be conducted for 48 weeks in HIV infected, HLA*B5701 begative subjects who were initially suppressed on a HAART regiment that includes TDF/FTC QD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABC/3TC (Epzicom), NRTI | Other | Drug: Abacavir/Lamivudine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1 RNA ≤ 50 copies/mL by HIV-1 Ultrasensitive RNA, Quantitative.
- Treatment experienced subjects on virologically stable HAART regimen containing tenofovir-emtricitabine or tenofovir-lamivudine.
- Subject with CD4 cells that do not increase by 15% and/or that decrease by 15% over previous 12 months period.
- -≥ 18 years of age
- Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
Key exclusion criteria (5 listed)
- Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
- Patient who are HLA B5701 Positive
- Patient who are determined to have ≥2 thymidine analog mutations to RT
- History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.
- Patient is either pregnant at time of screening evaluation 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 |
|---|---|---|
| Abacavir/LamivudineAlso: ABC/3TCone tablet once a day | Drug | ABC/3TC (Epzicom), NRTI |
Primary outcome
Efficacy.
Time frame: 1 years
Proportion of patients with CD4 changes from baseline at week 24 and 48. Proportion of patients with plasma HIV-1 RNA <75 copies/mL at week 24 and 48
1 secondary outcome
Safety
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abacavir/Lamivudine in people with HiV1- Positive, run by Therapeutic Concepts at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy. (time frame: 1 years). 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 28 Apr 2017; AzTrials last refreshed its copy on 31 Oct 2026.