HIV InfectionsPhase 4AtLaSNCT00885482
Atazanavir and Lamivudine for Treatment Simplification
A Phase 4 study testing Lamiduvine (Epivir), Atazanavir (Reyataz) and Ritonavir (Norvir) in people with HIV Infections, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Objectives of the study: 1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir. 2. 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?
- Lamiduvine (Epivir), Atazanavir (Reyataz) and Ritonavir (Norvir)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
- Aged 18 years or older
- Who gave informed consent to the participation to the study
- With at least two viral load < 50 copies/mL in two consecutive determinations at least 3 months apart
- With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least
Who cannot join
- Pregnancy or breast feeding, desire of pregnancy in the short term
- Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues
- Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
- Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
- Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response.
Objectives of the study:
- To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
- To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.
Read the detailed description
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density.
Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.
- Conditions
- HIV Infections
- Being tested
- Lamiduvine (Epivir), Atazanavir (Reyataz), Ritonavir (Norvir)
- Keywords
- HIV/AIDS, HAART, Simplification, Atazanavir, Lamivudine, 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.
Lamiduvine (Epivir)Drug
Epivir 300 mg
Atazanavir (Reyataz)Drug
Reyataz 300 mg
Ritonavir (Norvir)Drug
Norvir 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy. Receives: Drug: Lamiduvine (Epivir); Drug: Atazanavir (Reyataz); Drug: Ritonavir (Norvir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
Measured: 48 weeks
Secondary outcomes (8)
Time to Virological Failure at Survival Analysis
Measured: 48 weeks
Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis
Measured: 48 weeks
Evolution of CD4 Cell Count During the 48 Weeks
Measured: 48 weeks
Evolution of Adherence and Quality of Life During the 48 Weeks
Measured: 48 weeks
Evolution of Atazanavir Plasma Concentrations During the 48 Weeks
Measured: 48 weeks
Change of Metabolic Parameters at 48 Weeks
Measured: 48 weeks
Change of the Results of Neurocognitive Tests at 48 Weeks
Measured: 48 weeks
Change of Bone Density and of Subcutaneous Fat at 48 Weeks
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 posted22 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 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 (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea De Luca, Catholic University of the Sacred Heart
- Investigators
- Andrea De Luca, MD, Principal investigator, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885482
- Sponsor's protocol ID
- 2009-011273-32
- Other IDs
- 2009
- Acronym
- AtLaS
- Status last verified
- Feb 2015
- First submitted
- 20 Apr 2009
- Last updated
- 13 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fabbiani M, Bracciale L, Doino M, D'Avino A, Marzocchetti A, Navarra P, Cauda R, De Luca A, Di Giambenedetto S. Tenofovir discontinuation could predispose to urolithiasis in atazanavir-treated patients. J Infect. 2011 Apr;62(4):319-21. doi: 10.1016/j.jinf.2011.02.004. Epub 2011 Feb 15. No abstract available.
PubMed 21329725
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response.
- ClinicalTrials.gov ID
- NCT00885482
- Acronym / sponsor ID
- AtLaS / 2009-011273-32
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, HAART, Simplification, Atazanavir, Lamivudine, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives of the study:
- To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
- To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.
Detailed description
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density.
Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.
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: Lamiduvine (Epivir), Drug: Atazanavir (Reyataz), Drug: Ritonavir (Norvir)Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
- Aged 18 years or older
- Who gave informed consent to the participation to the study
- With at least two viral load < 50 copies/mL in two consecutive determinations at least 3 months apart
- With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least
Key exclusion criteria (5 listed)
- Pregnancy or breast feeding, desire of pregnancy in the short term
- Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues
- Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
- Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
- Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications
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 |
|---|---|---|
| Lamiduvine (Epivir)Epivir 300 mg | Drug | Single arm |
| Atazanavir (Reyataz)Reyataz 300 mg | Drug | Single arm |
| Ritonavir (Norvir)Norvir 100 mg | Drug | Single arm |
Primary outcome
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
Time frame: 48 weeks
8 secondary outcomes
Time to Virological Failure at Survival Analysis
Time frame: 48 weeks
Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis
Time frame: 48 weeks
Evolution of CD4 Cell Count During the 48 Weeks
Time frame: 48 weeks
Evolution of Adherence and Quality of Life During the 48 Weeks
Time frame: 48 weeks
Evolution of Atazanavir Plasma Concentrations During the 48 Weeks
Time frame: 48 weeks
Change of Metabolic Parameters at 48 Weeks
Time frame: 48 weeks
Change of the Results of Neurocognitive Tests at 48 Weeks
Time frame: 48 weeks
Change of Bone Density and of Subcutaneous Fat at 48 Weeks
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21329725Fabbiani M, Bracciale L, Doino M, D'Avino A, Marzocchetti A, Navarra P, Cauda R, De Luca A, Di Giambenedetto S. Tenofovir discontinuation could predispose to urolithiasis in atazanavir-treated patients. J Infect. 2011 Apr;62(4):319-21. doi: 10.1016/j.jinf.2011.02.004. Epub 2011 Feb 15. No abstract available.
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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.
Andrea De Luca, MD principal investigator
Catholic University of Sacred Heart
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 Lamiduvine (Epivir), Atazanavir (Reyataz) and Ritonavir (Norvir) in people with HIV Infections, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 5 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 13 Mar 2015. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2015). 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?
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis (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 NCT00885482, which also lists 1 linked publication.
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 13 Mar 2015.