HIV InfectionsPhase 4ONCENCT00615745
ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla
A Phase 4 study testing Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.
Trial summary
A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have documented HIV 1 infection by Roche Amplicor (Version 1.5 Ultra sensitive) or equivalent assay - either at screening or previously documented in the patient's medical record.
- Stable HAART regimen of efavirenz, emtricitabine and tenofovir DF for equal to or greater than 24 weeks prior to Screening and must be on their first HAART regimen.
- Undetectable plasma HIV 1 RNA (less than 50 copies/mL) at Screening and greater than or equal to 12 weeks prior to Screening.
- Greater than or equal to 18 years old.
- Adequate renal function by: Estimated creatinine clearance greater than or equal to 60 mL/min according to the Cockcroft Gault formula
- Hepatic transaminases (AST and ALT) less than or equal to 5 times upper limit of normal (ULN)
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- Total bilirubin less than or equal to 1.5 mg/dL
- Adequate hematologic function (absolute neutrophil count greater than or equal to 1,000/mm3; platelets greater than or equal to 25,000/mm3; hemoglobin greater than or equal to 8.0 g/dL
- Serum amylase less than or equal to 1.5 times ULN (subjects with serum amylase greater than 1.5 times ULN will remain eligible if serum lipase is less than or equal to 1.5 times ULN)
- Negative serum pregnancy test (females of childbearing potential only i.e., not surgically sterile or at least two years post-menopausal)
- Women of childbearing potential (WOCBP) must be willing to use two methods of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drugs in such a manner that the risk of pregnancy is minimized. Subjects may choose two (a barrier and highly effective method) of the birth control methods listed below: Hormonal birth control drugs, Male or female condoms with or without spermicidal gels, Diaphragm cervical cap with or without spermicidal gels, Intrauterine device
- Female subjects who utilize hormone contraceptive as one of their birth control methods must have used the same methods for at least three months prior to study dosing.
- Female subjects who are postmenopausal for less than two years are required to have FSH greater than or equal to 40 mIU/mL. If the FSH is less than 40 mIU/mL, the subject must agree to use highly effective method of birth control (as described above) to participate in the study.
- Male subjects who are sexually active must be willing to use effective barrier contraception (e.g., condom with spermicide) during heterosexual intercourse from screening through completion of the study and continuing for up to 12 weeks after the last dose of study drugs.
- Life expectancy greater than or equal to 1 year.
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Who cannot join
- Known hypersensitivity or toxicities to emtricitabine (FTC), tenofovir DF (TDF) or Truvada
- Known hypersensitivity or toxicities to Sustiva
- Have a history of resistance to any of the study agents at the time of screening (documented presence of resistance mutation(s) as defined by the IAS-USA 2007 Guidelines
- A new AIDS-defining condition diagnosed within the 30 days prior to the Baseline visit.
- Pregnant/lactating or breastfeeding females
- Severe hepatic impairment (greater than 5 times upper limit of normal as defined by laboratory transaminases) or deemed clinically significant by investigator.
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- Any currently known clinical or laboratory parameter of GSI Grade 4. However asymptomatic grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding AEs and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrollment.
- Receiving on-going therapy with any of the prohibited medications. Administration of any of the medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period.
- Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy within 30 days prior to Screening visit.
- Current acute illness or infection (e.g., opportunistic) - including an active AIDS defining condition within the previous six months.
- Hepatitis B coinfection or Hepatitis C coinfection
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS with 30 days of Baseline visit and are not anticipated to require systemic therapy during the study.
- Prior history of renal or bone disease deemed significant by the investigator.
- Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied has been stopped for more than 1 month.
- Evidence of alcohol and/or drug or substance abuse that in the judgment of the investigator would likely result in the patient being unreliable in fulfilling the conditions of the protocol.
- History of psychological illness or conditions that in the judgment of the investigator might interfere with the patient's ability to understand the requirements of the study.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements and cause the patient to be unable to complete the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Open-label, Prospective Observational Study to Evaluate Virological Response in Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla (Efavirenz/Emtricitabine/Tenofovir DF) on an Empty Stomach
A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification that in turn may increase adherence and improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety and tolerability) of a STR simplification strategy in patients on HAART who have achieved viral suppression in a real world clinical setting.
Read the detailed description
This is a prospective study to evaluate pure virological response rates in antiretroviral-experienced HIV infected subjects initiating therapy with Atripla. Subjects will be switching to Atripla having already been established on the individual components of efavirenz, emtricitabine, and tenofovir DF.
Within the Chelsea and Westminster hospital approximately 540 subjects have been identified who are currently receiving the individual components of Atripla and who would eventually switch to Atripla. The Royal Sussex County Hospital will be included to ensure that recruitment timelines are met.
A minimum of 150 subjects will be switched within the first 6 months allowing initial 24 week data for these subjects to be available approximately 12 months post launch.
- Conditions
- HIV Infections
- Being tested
- Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg
- Keywords
- Human Immunodeficiency Virus, treatment experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mgDrug
Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime. Receives: Drug: Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the proportion of subjects who maintain pure virologic response at HIV 1 RNA threshold of 50 copies/mL (PVR50; lack of confirmed HIV 1 RNA level greater or equal to 50 copies/mL) through Week 48.
Measured: 48 weeks
Secondary outcomes (4)
Proportion of subjects who have pure virologic response at HIV 1 RNA threshold of 400 copies/mL (PVR400; lack of confirmed HIV 1 RNA level greater or equal to 400 copies/mL) through Week 48.
Measured: 48 weeks
Proportion of subjects who have PVR50 at Week 24.
Measured: 24 weeks
Proportion of subjects who have PVR400 at Week 24.
Measured: 24 weeks
Change from baseline in CD4 cell count through 48 weeks of treatment.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cham Herath, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615745
- Sponsor's protocol ID
- GS-EU-177-0111
- Other IDs
- EudraCT Number 2007-005769-36
- Acronym
- ONCE
- Status last verified
- Nov 2011
- First submitted
- 4 Feb 2008
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Prospective Observational Study to Evaluate Virological Response in Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla (Efavirenz/Emtricitabine/Tenofovir DF) on an Empty Stomach
- ClinicalTrials.gov ID
- NCT00615745
- Acronym / sponsor ID
- ONCE / GS-EU-177-0111
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Feb 2008 (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.
A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification that in turn may increase adherence and improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety and tolerability) of a STR simplification strategy in patients on HAART who have achieved viral suppression in a real world clinical setting.
Detailed description
This is a prospective study to evaluate pure virological response rates in antiretroviral-experienced HIV infected subjects initiating therapy with Atripla. Subjects will be switching to Atripla having already been established on the individual components of efavirenz, emtricitabine, and tenofovir DF.
Within the Chelsea and Westminster hospital approximately 540 subjects have been identified who are currently receiving the individual components of Atripla and who would eventually switch to Atripla. The Royal Sussex County Hospital will be included to ensure that recruitment timelines are met.
A minimum of 150 subjects will be switched within the first 6 months allowing initial 24 week data for these subjects to be available approximately 12 months post launch.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mgAtripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient must have documented HIV 1 infection by Roche Amplicor (Version 1.5 Ultra sensitive) or equivalent assay - either at screening or previously documented in the patient's medical record.
- Stable HAART regimen of efavirenz, emtricitabine and tenofovir DF for equal to or greater than 24 weeks prior to Screening and must be on their first HAART regimen.
- Undetectable plasma HIV 1 RNA (less than 50 copies/mL) at Screening and greater than or equal to 12 weeks prior to Screening.
- Greater than or equal to 18 years old.
- Adequate renal function by: Estimated creatinine clearance greater than or equal to 60 mL/min according to the Cockcroft Gault formula
Key exclusion criteria (17 listed)
- Known hypersensitivity or toxicities to emtricitabine (FTC), tenofovir DF (TDF) or Truvada
- Known hypersensitivity or toxicities to Sustiva
- Have a history of resistance to any of the study agents at the time of screening (documented presence of resistance mutation(s) as defined by the IAS-USA 2007 Guidelines
- A new AIDS-defining condition diagnosed within the 30 days prior to the Baseline visit.
- Pregnant/lactating or breastfeeding females
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 |
|---|---|---|
| Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mgAtripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg as one tablet orally once daily taken on an empty stomach at bedtime. | Drug | Single Arm |
Primary outcome
The primary efficacy endpoint is the proportion of subjects who maintain pure virologic response at HIV 1 RNA threshold of 50 copies/mL (PVR50; lack of confirmed HIV 1 RNA level greater or equal to 50 copies/mL) through Week 48.
Time frame: 48 weeks
4 secondary outcomes
Proportion of subjects who have pure virologic response at HIV 1 RNA threshold of 400 copies/mL (PVR400; lack of confirmed HIV 1 RNA level greater or equal to 400 copies/mL) through Week 48.
Time frame: 48 weeks
Proportion of subjects who have PVR50 at Week 24.
Time frame: 24 weeks
Proportion of subjects who have PVR400 at Week 24.
Time frame: 24 weeks
Change from baseline in CD4 cell count through 48 weeks of treatment.
Time frame: 48 weeks
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 21 Nov 2011.
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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.
Cham Herath study director
Gilead Sciences
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 Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.
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 17 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 21 Nov 2011. 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 Kingdom. 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?
The primary efficacy endpoint is the proportion of subjects who maintain pure virologic response at HIV 1 RNA threshold of 50 copies/mL (PVR50; lack of confirmed HIV 1 RNA level greater or equal to 50 copies/mL) through Week 48. (time frame: 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 21 Nov 2011.