Human Immunodeficiency Virus (HIV)Phase 4NCT00335322
ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens
A Phase 4 study testing Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz), Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) and Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) in people with Human Immunodeficiency Virus (HIV), run by Kirby Institute.
Trial summary
In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz), Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) and Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Nov 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6 months from date of randomisation.
- Aged > 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate).
- Antiretroviral treatment naïve.
- Qualifying plasma HIV RNA > 2,000 copies/mL and a CD4+ T cell count of ≥ 50 cells/µL.
- No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing).
- Calculated creatinine clearance (CLCr) greater than or equal to 70 mL/min (Cockcroft-Gault formula).
- Able to provide written informed consent.
Who cannot join
- The following laboratory variables,
- absolute neutrophil count (ANC) < 750 cells/µL
- haemoglobin < 8.0 g/dL
- platelet count < 50,000 cells/µL
- serum AST, ALT > 5 x upper limit of normal (ULN)
- serum bilirubin > 1.5 x ULN
Show all 18Show fewer
- Pregnant or nursing mothers.
- Current use of human growth hormone, testosterone or other anabolic steroid.
- Current use of any prohibited medications as described in product specific information.
- Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation.
- Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
- Patients unlikely to be able to remain in follow-up for the protocol-defined period.
- Patients with known renal insufficiency.
- Patients with obstructive liver disease.
- Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days).
- History of acute or chronic pancreatitis.
- Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).
About this study
Official title: A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection.
In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.
Read the detailed description
The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-RNA, and safety, of three strategic regimens of initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. (Primary comparisons are regimen I versus II and I versus III as described below).
- tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) + emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC) + zidovudine (ZDV) + abacavir (ABC)
Secondary objectives of this study will be to undertake a range of analyses including but not limited to the following,
- Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL) at week 48 and week 96 between treatment arms.
- Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400 copies/mL) between treatment arms.
- Time to virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL (and 400 copies/mL) after confirmed < 50 copies/mL (where time = 0 if patient never achieves plasma virus load < 50 or <400 copies/mL).
- Mean change from baseline of absolute CD4+ T cell count at weeks 48 and 96 between treatment arms.
- Time to change in randomly assigned therapy (all reasons individually and on aggregate) between treatment arms.
- Time to first virologic failure (defined as #3 above) or cessation of randomly assigned antiretroviral therapy.
- Mean change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between treatment arms.
- Mean change from baseline in peripheral and central adipose tissue, as measured by CT and DEXA at weeks 48 and 96 between treatment arms.
- Mean change from baseline in fasting lipid and glycemic parameters at weeks 48 and 96 between treatment arms.
- Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs, between treatment arms.
- Comparison of total number of patients with any adverse events (AEs), and the cumulative incidence of AEs, associated with cessation of randomly assigned therapy between treatment arms.
- Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms.
- Describe aspects of immune reconstitution disease.
- Adherence to therapy and associations with virologic outcomes between treatment arms.
- Comparison of quality of life between treatment arms.
Following the result of the scheduled week 48 data analysis, the protocol steering committee amended the study protocol as follows:
- Patients on Arms I and II will remain on the current study drugs
- Patients on Arm III may be switched at the physician's discretion to either Arm I or II
- There will be a protocol amendment to include one extra follow up visit at week 144 for all patients, regardless of treatment arm or current treatment
- All patients are to be encouraged to stay on the study up to week 144, to maximize follow up on study.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz), Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV), Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
- Keywords
- Human Immunodeficiency Virus (HIV)
- 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.
Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)Drug
Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)Drug
Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food)
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)Drug
Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin efavirenz) Receives: Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz) |
| 2 | Active comparator | Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) Receives: Drug: Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) |
| 3 | Experimental | Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) Receives: Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Mean Change From Baseline Plasma HIV-RNA.
Measured: 48 weeks
Secondary outcomes (1)
Time Weighted Mean Change From Baseline Plasma HIV-RNA
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startFeb 2007
- Primary completionMar 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- David A Cooper, AO DSc MD FRACP FRCPA FRCP, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335322
- Sponsor's protocol ID
- NCHECR-ALTAIR
- Status last verified
- Sep 2019
- First submitted
- 8 Jun 2006
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Puls RL, Srasuebkul P, Petoumenos K, Boesecke C, Duncombe C, Belloso WH, Molina JM, Li L, Avihingsanon A, Gazzard B, Cooper DA, Emery S; Altair Study Group. Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Clin Infect Dis. 2010 Oct 1;51(7):855-64. doi: 10.1086/656363.
PubMed 20735258Winston A, Duncombe C, Li PC, Gill JM, Kerr SJ, Puls R, Petoumenos K, Taylor-Robinson SD, Emery S, Cooper DA; Altair Study Group. Does choice of combination antiretroviral therapy (cART) alter changes in cerebral function testing after 48 weeks in treatment-naive, HIV-1-infected individuals commencing cART? A randomized, controlled study. Clin Infect Dis. 2010 Mar 15;50(6):920-9. doi: 10.1086/650743.
PubMed 20146627Berthon-Jones N, Courtney-Vega K, Donaldson A, Haskelberg H, Emery S, Puls R. Assessing site performance in the Altair study, a multinational clinical trial. Trials. 2015 Apr 8;16:138. doi: 10.1186/s13063-015-0653-x.
PubMed 25872747
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection.
- ClinicalTrials.gov ID
- NCT00335322
- Acronym / sponsor ID
- NCHECR-ALTAIR
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Human Immunodeficiency Virus (HIV)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales
- Study start
- Feb 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Jun 2006 (estimated)
- Results
- Posted 15 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.
Detailed description
The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-RNA, and safety, of three strategic regimens of initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. (Primary comparisons are regimen I versus II and I versus III as described below).
- tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) + emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC) + zidovudine (ZDV) + abacavir (ABC)
Secondary objectives of this study will be to undertake a range of analyses including but not limited to the following,
- Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL) at week 48 and week 96 between treatment arms.
- Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400 copies/mL) between treatment arms.
- Time to virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL (and 400 copies/mL) after confirmed < 50 copies/mL (where time = 0 if patient never achieves plasma virus load < 50 or <400 copies/mL).
- Mean change from baseline of absolute CD4+ T cell count at weeks 48 and 96 between treatment arms.
- Time to change in randomly assigned therapy (all reasons individually and on aggregate) between treatment arms.
- Time to first virologic failure (defined as #3 above) or cessation of randomly assigned antiretroviral therapy.
- Mean change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between treatment arms.
- Mean change from baseline in peripheral and central adipose tissue, as measured by CT and DEXA at weeks 48 and 96 between treatment arms.
- Mean change from baseline in fasting lipid and glycemic parameters at weeks 48 and 96 between treatment arms.
- Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs, between treatment arms.
- Comparison of total number of patients with any adverse events (AEs), and the cumulative incidence of AEs, associated with cessation of randomly assigned therapy between treatment arms.
- Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms.
- Describe aspects of immune reconstitution disease.
- Adherence to therapy and associations with virologic outcomes between treatment arms.
- Comparison of quality of life between treatment arms.
Following the result of the scheduled week 48 data analysis, the protocol steering committee amended the study protocol as follows:
- Patients on Arms I and II will remain on the current study drugs
- Patients on Arm III may be switched at the physician's discretion to either Arm I or II
- There will be a protocol amendment to include one extra follow up visit at week 144 for all patients, regardless of treatment arm or current treatment
- All patients are to be encouraged to stay on the study up to week 144, to maximize follow up on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin efavirenz) |
| 2 | Active comparator | Drug: Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) |
| 3 | Experimental | Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6 months from date of randomisation.
- Aged > 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate).
- Antiretroviral treatment naïve.
- Qualifying plasma HIV RNA > 2,000 copies/mL and a CD4+ T cell count of ≥ 50 cells/µL.
- No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing).
Key exclusion criteria (18 listed)
- The following laboratory variables,
- Pregnant or nursing mothers.
- Current use of human growth hormone, testosterone or other anabolic steroid.
- Current use of any prohibited medications as described in product specific information.
- Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation.
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 |
|---|---|---|
| Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily | Drug | 1 |
| Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food) | Drug | 2 |
| Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd | Drug | 3 |
Primary outcome
Time-weighted Mean Change From Baseline Plasma HIV-RNA.
Time frame: 48 weeks
1 secondary outcome
Time Weighted Mean Change From Baseline Plasma HIV-RNA
Time frame: 144 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20735258Puls RL, Srasuebkul P, Petoumenos K, Boesecke C, Duncombe C, Belloso WH, Molina JM, Li L, Avihingsanon A, Gazzard B, Cooper DA, Emery S; Altair Study Group. Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Clin Infect Dis. 2010 Oct 1;51(7):855-64. doi: 10.1086/656363.
- Results publication: PubMed 20146627Winston A, Duncombe C, Li PC, Gill JM, Kerr SJ, Puls R, Petoumenos K, Taylor-Robinson SD, Emery S, Cooper DA; Altair Study Group. Does choice of combination antiretroviral therapy (cART) alter changes in cerebral function testing after 48 weeks in treatment-naive, HIV-1-infected individuals commencing cART? A randomized, controlled study. Clin Infect Dis. 2010 Mar 15;50(6):920-9. doi: 10.1086/650743.
- Derived from this study: PubMed 25872747Berthon-Jones N, Courtney-Vega K, Donaldson A, Haskelberg H, Emery S, Puls R. Assessing site performance in the Altair study, a multinational clinical trial. Trials. 2015 Apr 8;16:138. doi: 10.1186/s13063-015-0653-x.
- The Kirby Institute homepage (formerly known as the National Centre in HIV Epidemiology and Clinical Research)Link provided by the sponsor.
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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.
David A Cooper, AO DSc MD FRACP FRCPA FRCP principal investigator
Kirby Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz), Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) and Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) in people with Human Immunodeficiency Virus (HIV), run by Kirby Institute.
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 7 inclusion and 18 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 26 Sep 2019. 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 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?
Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-weighted Mean Change From Baseline Plasma HIV-RNA. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335322, which also lists 3 linked publications.
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 26 Sep 2019.