QoL and Adherence to One-pill Once-a-day HAART (ADONE)

A.O. Ospedale Papa Giovanni XXIII

Status and phase: Completed; Phase 3

Conditions: HIV Infection; HIV Infections

Treatments: Other: reduced number of pills

Study type: Interventional

Funder types: Other

Identifiers

NCT00990600

ADONE

EUDRACT NUMBER: 2007-007839-33

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

212 participants in 1 patient group

Simplified one pill regimen

Experimental group

Description:

Fixed dose combination of tenofovir + emtricitabine + efavirenz

Treatment:

Other: reduced number of pills