NCT00876733

Brief Summary

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
605

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

66 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

March 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

4.8 years

First QC Date

March 20, 2009

Results QC Date

December 27, 2014

Last Update Submit

January 14, 2015

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs

    Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs

    36 months

Secondary Outcomes (24)

  • Changes in the Viral Load After 12 Months From Baseline.

    Baseline and 12 months

  • Changes in the Viral Load After 36 Months From Baseline.

    Baseline and 36 months

  • Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.

    Baseline and 12 months

  • Changes in the CD4+ Cell Count After 36 Months From Baseline.

    Baseline and 36 months

  • Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline

    Baseline and 12 months

  • +19 more secondary outcomes

Study Arms (1)

HIV treatment

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:

  • male and female
  • years or older
  • written informed consent

You may not qualify if:

  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (66)

Boehringer Ingelheim Investigational Site 14

Aachen, Germany

Location

Boehringer Ingelheim Investigational Site 12

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 13

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 15

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 19

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 21

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 23

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 24

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 28

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 30

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 31

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 34

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 38

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 41

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 54

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 60

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 63

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 8

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 58

Bochum, Germany

Location

Boehringer Ingelheim Investigational Site 50

Chemnitz, Germany

Location

Boehringer Ingelheim Investigational Site 53

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site 61

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site 48

Dortmund, Germany

Location

Boehringer Ingelheim Investigational Site 27

Duisburg, Germany

Location

Boehringer Ingelheim Investigational Site 49

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 62

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 9

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 32

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 59

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 65

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 57

Freiburg im Breisgau, Germany

Location

Boehringer Ingelheim Investigational Site 56

Fürth, Germany

Location

Boehringer Ingelheim Investigational Site 29

Giessen, Germany

Location

Boehringer Ingelheim Investigational Site 33

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 42

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 47

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 51

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 40

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 43

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 46

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 6

Karlsruhe, Germany

Location

Boehringer Ingelheim Investigational Site 25

Koblenz, Germany

Location

Boehringer Ingelheim Investigational Site 37

Krefeld, Germany

Location

Boehringer Ingelheim Investigational Site 11

Leipzig, Germany

Location

Boehringer Ingelheim Investigational Site 52

Mainz, Germany

Location

Boehringer Ingelheim Investigational Site 18

München, Germany

Location

Boehringer Ingelheim Investigational Site 20

München, Germany

Location

Boehringer Ingelheim Investigational Site 22

München, Germany

Location

Boehringer Ingelheim Investigational Site 26

München, Germany

Location

Boehringer Ingelheim Investigational Site 35

München, Germany

Location

Boehringer Ingelheim Investigational Site 5

München, Germany

Location

Boehringer Ingelheim Investigational Site 16

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 17

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 39

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 55

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 10

Neuss, Germany

Location

Boehringer Ingelheim Investigational Site 36

Oldenburg, Germany

Location

Boehringer Ingelheim Investigational Site 64

Osnabrück, Germany

Location

Boehringer Ingelheim Investigational Site 7

Pforzheim, Germany

Location

Boehringer Ingelheim Investigational Site 66

Potsdam, Germany

Location

Boehringer Ingelheim Investigational Site 1

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 3

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 4

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 45

Troisdorf, Germany

Location

Boehringer Ingelheim Investigational Site 2

Wiesbaden, Germany

Location

Boehringer Ingelheim Investigational Site 44

Wuppertal, Germany

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

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

March 20, 2009

First Posted

April 7, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01

Locations

DE(66)