CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Lamiduvine (Epivir) +2 moredrug
Likely dose
Lamiduvine (Epivir) 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00885482
NCT00885482Phase 4Completed
CompareCT.gov

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.

Catholic University of the Sacred Heart·interventional·Posted Apr 22, 2009·Updated Mar 13, 2015

In Brief

A Phase 4 clinical trial evaluating Lamiduvine (Epivir), Atazanavir (Reyataz), and 1 other intervention for HIV Infections. Completed, enrolled 40 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2009
Enrollment StartMay 1, 2009
Primary CompletionMay 1, 2010
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.2 years ago

Interventions

Lamiduvine (Epivir)drug

Epivir 300 mg

Atazanavir (Reyataz)drug

Reyataz 300 mg

Ritonavir (Norvir)drug

Norvir 100 mg