NCT01049685

Brief Summary

Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA \<50 copies/mL) in the first six months and at the end of the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Aug 2006

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 15, 2010

Status Verified

January 1, 2010

Enrollment Period

3.3 years

First QC Date

January 11, 2010

Last Update Submit

February 12, 2010

Conditions

HIV Infections

Keywords

HIVAntiretroviral Therapy, Highly ActiveEfavirenzLopinavirComparative Effectiveness ResearchTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Maintenance HIV RNA <50 copies/mL at the end oh 36 months

    36 months

Secondary Outcomes (1)

  • Achieve HIV RNA <50 copies/mL at the first 6 months

    6 months

Study Arms (2)

Efavirenz Group

ACTIVE COMPARATOR

Naïve-treatment HIV patients, who started therapy with Efavirenz

Drug: First-line Antiretroviral Therapy

Lopinavir/r Group

ACTIVE COMPARATOR

Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir

Drug: First-line Antiretroviral Therapy

Interventions

First-line Antiretroviral TherapyDRUG

* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background * Efavirenz: 01 capsules day, plus NRTI background

Also known as: Sustiva, Kaletra
Efavirenz GroupLopinavir/r Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infected naive-treatment patients

You may not qualify if:

  • use of Anti-Retroviral Agents in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAE e Hospital Dia Domingos Alves Meira

Botucatu, São Paulo, 18603-790, Brazil

Location

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenzlopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Alexandre N Barbosa, MD, MSc

    Botucatu School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 14, 2010

Study Start

August 1, 2006

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

February 15, 2010

Record last verified: 2010-01

Locations

BR(1)