An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients

NCT01615601 | Completed

• 2 other identifiers: CR018595TMC114HIV4068
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are naïve to these medications and in patients who have experienced tolerability issues on their current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by switching the patients from their previous or current combination antiretroviral therapy (cART) to either darunavir or etravirine.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Human Immunodeficiency Virus; HIV; HIV-1; HIV type 1; Darunavir; PREZISTA; Etravirine; INTELENCE; HIV symptom Distress Module; HIV-SDM; Antiretroviral therapy; HIV Symptom Index (HSI),

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the patient's total score of the HIV Symptom Distress Module (HIV-SDM)

  HIV-SDM is a questionnaire consisting of 20 questions related to all the symptoms which the patient might have had during the past four weeks. For each question patient has to select appropriate answer related to the symptoms: "0 = I do not have this symptom; 1 = I have this symptom and it doesn't bother me; 2 = it bothers me a little; 3 = it bothers me; 4 = it bothers me a lot". Total score of HIV-SDM is then calculated for all the 20 items.

  Baseline (Day 1), Week 4, 12 and 24

Secondary Outcomes (5)

• Number of participants with Maintenance/achievement of virologic suppression at Week 24

  Baseline and Week 24

• Number of participants with disappearance by Week 4 of at least one bothersome symptom identified at baseline by patient on HIV-SDM

  Baseline and Week 4

• Number of participants with maintenance of disappearance by Week 12 and Week 24 of at least one bothersome symptom identified at baseline by patient on HIV-SDM

  Baseline, Week 12 and Week 24

• Number of participants with Maintenance/increase in CD4 cell count.

  Baseline and Week 24

• Comparison of change in HIV-SDM scores between those participants who were on or off ARTs at baseline

  Baseline, Week 4, Week 12 and Week 24

Study Arms (2)

darunavir (PREZISTA)

PREZISTA co-administered with 100 mg ritonavir as per Canadian Product Monograph. (Observational Study)

Drug: darunavir (PREZISTA); Drug: ritonavir

etravirine (INTELENCE)

INTELENCE co-administered with other antiretroviral medicinal products as per Canadian Product Monograph (Observational Study)

Drug: etravirine (INTELENCE); Drug: Other antiretroviral medications

Interventions

darunavir (PREZISTA) DRUG

Form = tablet, route = oral, Units = mg, number = 800 administered once daily

darunavir (PREZISTA)

etravirine (INTELENCE) DRUG

Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily

etravirine (INTELENCE)

ritonavir DRUG

Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily

darunavir (PREZISTA)

Other antiretroviral medications DRUG

Given as per Canadian Product Monograph

etravirine (INTELENCE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients infected with human immunodeficiency virus type 1 who have experienced tolerability issues on their current or prior ccombination antiretroviral therapy regimen and for whom a regimen including darunavir and/or etravirine is clinically indicated.

You may qualify if:

• Have a documented HIV-1 infection
• Have 1 or more significant symptoms with at least grade 2 toxicity on the Division of AIDS Toxicity "DAIDS grading scale" on current or prior combination antiretroviral therapy (cART) regimen (current or prior cART including regimens consisting of 2 Nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent with the exception of darunavir or etravirine)
• Have stable response to current cART ie, have an HIV-plasma viral load \[number of virus in blood\] at screening \<400 copies/mL (undetectable) or last plasma viral load on prior regimen within the previous 6 months \<400 copies/mL)
• Must not have resistance to Primary HIV protease inhibitor medicines

You may not qualify if:

• Has been Infected with HIV-2 - Has received previous treatment with darunavir or etravirine or non-HAART (Highly Active Antiretroviral Therapy) regimen
• Has had prior virologic failure to 2 or more regimens or single virologic failure on prior cART
• Has a documented resistance to darunavir and etravirine
• Is currently using any drug contraindicated in the current Canadian Product Monograph for darunavir or etravirine

Sponsors & Collaborators

• Janssen Inc.: lead

Study Sites (1)

Unknown Facility

Vancouver, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir; etravirine; Ritonavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

CA (1)