QoL and Adherence to One-pill Once-a-day HAART (ADONE)
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ClinicalTrials.gov Identifier: NCT00990600 |
Recruitment Status
:
Completed
First Posted
: October 7, 2009
Last Update Posted
: October 29, 2009
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection HIV Infections | Other: reduced number of pills | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 212 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Adherence to a One Pill, Once-a-day Antiretroviral Regimen |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Simplified one pill regimen
Fixed dose combination of tenofovir + emtricitabine + efavirenz
|
Other: reduced number of pills
Switch to a fixed dose combination one pill/daily HAART
Other Names:
|
- Proportion of adherence to HAART [ Time Frame: 6 months ]
- QoL (VAS scale) preferences of patients virologic and immunologic outcomes [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
- Any ongoing grade 4 laboratory abnormality

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990600
Principal Investigator: | Franco Maggiolo, MD | Ospedali Riuniti, Bergamo |
Responsible Party: | Franco Maggiolo MD, Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo |
ClinicalTrials.gov Identifier: | NCT00990600 History of Changes |
Other Study ID Numbers: |
ADONE EUDRACT NUMBER: 2007-007839-33 |
First Posted: | October 7, 2009 Key Record Dates |
Last Update Posted: | October 29, 2009 |
Last Verified: | October 2009 |
Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
adherence Qol virologic efficacy immunologic efficacy |
patients' preference once-daily HAART treatment experienced |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Tenofovir Emtricitabine |
Efavirenz Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |