NNRTI/PI Toxicity Switch to Darunavir Study

NCT00765154 | Terminated Phase 4

• 1 other identifier: SSAT 028
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine the effects of switching from antiretroviral combinations that includes efavirenz (Sustiva®), lopinavir/ritonavir (Kaletra®) or atazanavir/ritonavir (Reyataz®/Norvir®) in individuals experiencing side effects from one of these agents, and replacing these with a new HIV medication called Darunavir also given with ritonavir (Norvir®). The study will primarily investigate the effect of change in medication on the subjects viral load (the levels of the HIV virus in the blood), on immunological parameters (CD4 count) and on other safety parameters (such as cholesterol) and also quality of life.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• The improvement of NNRTI/PI associated toxicity after 4 weeks of therapy with ritonavir boosted darunavir.

  20 days

Secondary Outcomes (7)

• Viral load suppression below 50 copies/ml post switch

  between 20 and 60 days

• Viral load < 400 copies/ml post switch

  between 20 and 60 days

• Toxicity

  60 days

• Health related quality of life questionnaires

  Baseline, 20 and 60 days

• Changes in fasting triglycerides post switch

  20 days and 60 days

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Immediate switch from NNRTI/PI to DRV/r

Drug: darunavir

Group 2

ACTIVE COMPARATOR

Switch after 10 weeks from NNRTI/PI to DRV/r

Drug: ritonavir

Interventions

darunavir DRUG

two 400mg tablets (800mg) once daily

Also known as: TMC114, Trade Name: Prezista

Group 1

ritonavir DRUG

one 100mg capsule once daily

Also known as: Trade Name: Norvir

Group 2

Eligibility Criteria

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

You may qualify if:

• HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
• Subject is currently on an antiretroviral regimen comprising of at least three licensed antiretroviral agents including efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir
• Subject is virologically suppressed with a viral load \< 50 copies/ml
• Subject has a CD4+ count above 50 cells/ml
• If subject is a female of childbearing potential, she must agree to use a double barrier method of contraception
• No previous exposure to darunavir

You may not qualify if:

• Pregnant or lactating women
• Any female of childbearing potential not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs)
• Heterosexually active male subject not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational ARVs)

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Interventions

Darunavir; Ritonavir

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

• Mark Nelson

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 1, 2010

Record last verified: 2010-10

Locations

GB (1)