Trial Outcomes & Findings for Atazanavir and Lamivudine for Treatment Simplification (NCT NCT00885482)

NCT ID: NCT00885482

Last Updated: 2015-03-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2015-03-13

Participant Flow

Participant milestones

Measure	Single Arm Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Single Arm Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Overall Study Pregnancy	1
Overall Study Lack of Efficacy	1
Overall Study Death	1
Overall Study low Therapeutic drug monitoring (TDM)	1

Baseline Characteristics

Atazanavir and Lamivudine for Treatment Simplification

Baseline characteristics by cohort

Measure	Single Arm n=40 Participants Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment Italy	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Outcome measures

Measure	Single Arm n=40 Participants Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis	1 patients

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Arm n=40 participants at risk Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Renal and urinary disorders renal colics	10.0% 4/40 • Number of events 4
Vascular disorders hypertensive crisis	2.5% 1/40 • Number of events 1
Cardiac disorders brain hemorrage and subsequent myocardial infarction	2.5% 1/40 • Number of events 2

Other adverse events

Measure	Single Arm n=40 participants at risk Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Infections and infestations fever	37.5% 15/40 • Number of events 15

Additional Information

Andrea De Luca

Catholic University of S. Heart

Phone: +390630155366

Email: deluca.andrea@fastwebnet.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place