HIV InfectionPhase 3ADONENCT00990600
QoL and Adherence to One-pill Once-a-day HAART
A Phase 3 study testing reduced number of pills in people with HIV Infection and HIV Infections, run by A.O. Ospedale Papa Giovanni XXIII.
Trial summary
Primary objective of the study is: To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- reduced number of pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to May 2009
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Informed consent signed
- Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months
- Being on a stable HAART regimen based either on two possible drug associations:
- 3TC/FTC + TDF + EFV
- FTC/TDF (fixed dose combination) + EFV
- No previous documented virologic failure
Who cannot join
- Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
- Any ongoing grade 4 laboratory abnormality
About this study
Official title: Adherence to a One Pill, Once-a-day Antiretroviral Regimen
Primary objective of the study is:
To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.
- Conditions
- HIV Infection, HIV Infections
- Being tested
- reduced number of pills
- Keywords
- adherence, Qol, virologic efficacy, immunologic efficacy, patients' preference, once-daily, HAART, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced number of pillsOther
Also called efavirenz EFV, emtricitabine FTC, tenofovir TDF
Switch to a fixed dose combination one pill/daily HAART
| Study group | Role | What they receive |
|---|---|---|
| Simplified one pill regimen | Experimental | Fixed dose combination of tenofovir + emtricitabine + efavirenz Receives: Other: reduced number of pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adherence to HAART
Measured: 6 months
Secondary outcomes (1)
QoL (VAS scale) preferences of patients virologic and immunologic outcomes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Investigators
- Franco Maggiolo, MD, Principal investigator, Ospedali Riuniti, Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990600
- Sponsor's protocol ID
- ADONE
- Other IDs
- EUDRACT NUMBER: 2007-007839-33
- Acronym
- ADONE
- Status last verified
- Oct 2009
- First submitted
- 6 Oct 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to a One Pill, Once-a-day Antiretroviral Regimen
- ClinicalTrials.gov ID
- NCT00990600
- Acronym / sponsor ID
- ADONE / ADONE
- Conditions
- HIV Infection, HIV Infections
- Keywords
- adherence, Qol, virologic efficacy, immunologic efficacy, patients' preference, once-daily, HAART, treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Oct 2009 (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.
Primary objective of the study is:
To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simplified one pill regimen | Experimental | Other: reduced number of pillsFixed dose combination of tenofovir + emtricitabine + efavirenz |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Informed consent signed
- Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months
- Being on a stable HAART regimen based either on two possible drug associations:
- No previous documented virologic failure
Key exclusion criteria (2 listed)
- Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
- Any ongoing grade 4 laboratory abnormality
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 |
|---|---|---|
| reduced number of pillsAlso: efavirenz EFV, emtricitabine FTC, tenofovir TDFSwitch to a fixed dose combination one pill/daily HAART | Other | Simplified one pill regimen |
Primary outcome
Proportion of adherence to HAART
Time frame: 6 months
1 secondary outcome
QoL (VAS scale) preferences of patients virologic and immunologic outcomes
Time frame: 6 months
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 29 Oct 2009.
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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.
Franco Maggiolo, MD principal investigator
Ospedali Riuniti, Bergamo
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing reduced number of pills in people with HIV Infection and HIV Infections, run by A.O. Ospedale Papa Giovanni XXIII.
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 2 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 29 Oct 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of adherence to HAART (time frame: 6 months). 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 Oct 2009.