To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine

A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207168

Enrollment

120

Registered

2005-09-21

Start date

2004-04-30

Completion date

2006-12-31

Last updated

2011-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Brief summary

To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.

Interventions

BEHAVIORALCompliance

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential.

Exclusion criteria

* virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding

Design outcomes

Primary

Measure	Time frame
To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomized to receive either a once daily 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.	—

Secondary

Measure	Time frame
To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026