NCT00976950

Brief Summary

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

20 active sites

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

Study Start

First participant enrolled

September 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 16, 2012

Completed
Last Updated

March 20, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

September 14, 2009

Results QC Date

May 30, 2012

Last Update Submit

February 24, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Reporting Adverse Events (AE)

    Any type of adverse events

    48 weeks

Secondary Outcomes (2)

  • Virologic Response

    48 weeks

  • Change in CD4+ Cell Count From Baseline at Week 48

    48 weeks

Study Arms (1)

Patients with HIV-1 infection

Drug: TipranavirDrug: ritonavir

Interventions

TipranavirDRUG
Patients with HIV-1 infection
ritonavirDRUG

low-dose

Patients with HIV-1 infection

Eligibility Criteria

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

patients

You may qualify if:

  • HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Boehringer Ingelheim Investigational site 9

Arad, Romania

Location

Boehringer Ingelheim Investigational site 13

Bacau, Romania

Location

Boehringer Ingelheim Investigational site 17

Brasov, Romania

Location

Boehringer Ingelheim Investigational site 18

Brasov, Romania

Location

Boehringer Ingelheim Investigational site 19

Brasov, Romania

Location

Boehringer Ingelheim Investigational site 1

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 2

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 3

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 4

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 5

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 6

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 7

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 8

Bucharest, Romania

Location

Boehringer Ingelheim Investigational site 16

Constanța, Romania

Location

Boehringer Ingelheim Investigational site 11

Craiova, Romania

Location

Boehringer Ingelheim Investigational site 12

Craiova, Romania

Location

Boehringer Ingelheim Investigational site 15

Galati, Romania

Location

Boehringer Ingelheim Investigational site 20

Tg.Mures, Romania

Location

Boehringer Ingelheim Investigational site 10

Timișoara, Romania

Location

Boehringer Ingelheim Investigational site 14

Vaslui, Romania

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavirRitonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

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

September 14, 2009

First Posted

September 15, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

March 20, 2014

Results First Posted

August 16, 2012

Record last verified: 2014-02

Locations

RO(20)