NCT02581202

Brief Summary

This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 29, 2019

Completed
Last Updated

June 6, 2019

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

October 19, 2015

Results QC Date

May 23, 2018

Last Update Submit

May 22, 2019

Conditions

HIV-1 Infection

Keywords

antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48

    Week 48

Secondary Outcomes (35)

  • Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24

    Week 24

  • Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)

    Baseline, Week 24

  • Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)

    Baseline, Week 24

  • Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)

    Baseline, Week 48

  • Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)

    Baseline, Week 48

  • +30 more secondary outcomes

Study Arms (1)

HIV-1 infected participants

HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.

Drug: lopinavir/ritonavirDrug: lamivudine

Interventions

lopinavir/ritonavirDRUG

tablet

HIV-1 infected participants
lamivudineDRUG

tablet

HIV-1 infected participants

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC in the routine clinical settings.

You may qualify if:

  • Age 18 years and older (male and female).
  • HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level \<50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago.
  • Cumulative HAART experience at least 6 months.
  • Authorization (Consent) for Use/Disclosure of Data signed by the patient.

You may not qualify if:

  • Contraindications to lopinavir/ritonavir and lamivudine
  • Previous participation in this program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LopinavirLamivudine

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • Andrey Strugovschikov, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 20, 2015

Study Start

December 21, 2015

Primary Completion

May 27, 2017

Study Completion

May 27, 2017

Last Updated

June 6, 2019

Results First Posted

March 29, 2019

Record last verified: 2018-05