Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

NCT01134939 | Completed Results

• 1 other identifier: 1100.1536
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 34

Brief Summary

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Virologic Response (VR) After 36 Months

  VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.

  36 months

Secondary Outcomes (12)

• Changes in the Viral Load After 36 Months From Baseline

  Baseline and 36 months

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

  Baseline and 36 months

• Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline

  Baseline and 36 months

• Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline

  Baseline and 36 months

• Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline

  Baseline and 36 months

Study Arms (1)

HIV-infected women and men

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (34)

Boehringer Ingelheim Investigational Site 23

Aachen, Germany

Location

Boehringer Ingelheim Investigational Site 10

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 11

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 14

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 19

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 26

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 28

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 33

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 4

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 5

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 8

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 9

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 31

Chemnitz, Germany

Location

Boehringer Ingelheim Investigational Site 25

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site 29

Dortmund, Germany

Location

Boehringer Ingelheim Investigational Site 27

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 17

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 1

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 2

Freiburg im Breisgau, Germany

Location

Boehringer Ingelheim Investigational Site 34

Giessen, Germany

Location

Boehringer Ingelheim Investigational Site 22

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 6

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 12

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 16

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 32

Karlsruhe, Germany

Location

Boehringer Ingelheim Investigational Site 15

Koblenz, Germany

Location

Boehringer Ingelheim Investigational Site 21

Leipzig, Germany

Location

Boehringer Ingelheim Investigational Site 20

München, Germany

Location

Boehringer Ingelheim Investigational Site 24

München, Germany

Location

Boehringer Ingelheim Investigational Site 3

München, Germany

Location

Boehringer Ingelheim Investigational Site 7

München, Germany

Location

Boehringer Ingelheim Investigational Site 13

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 18

Osnabrück, Germany

Location

Boehringer Ingelheim Investigational Site 30

Stuttgart, Germany

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune 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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 21, 2015
• Results First Posted: January 21, 2015

Record last verified: 2015-01

Locations

DE (34)