Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125

NCT00792324 | Completed Phase 3

• 1 other identifier: SSAT 029
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine the effect of switching from an antiretroviral combination that includes efavirenz (Susitiva®), in individuals experiencing efavirenz-related side effects, and replacing this with an investigational HIV medication called Etravirine (TMC125). The study will primarily investigate the effect of change in medication on your viral load (the levels of the HIV virus in your blood), on immunological parameters (CD4 count), on other safety parameters (such as cholesterol) your side effects and also on your quality of life.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured by the proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity after 12 weeks (as defined by the ACTG adverse event scale).

  12 weeks

Secondary Outcomes (8)

• The rate of neuropsychiatric and central nervous system (CNS) toxicity after 12 and 24 weeks as measured by the change from baseline by the Hospital Anxiety and Depression Scale (HADS).

  12-24 weeks

• Proportion of patients with viral load below 50 copies/mL at weeks 12 and 24

  12-24 weeks

• Proportion of patients with viral load below 400 copies/mL at weeks 12 and 24

  12 and 24 weeks

• Change from baseline in CD4+ count at weeks 12 and 24

  12 and 24 weeks

• Change from baseline in laboratory parameters at weeks 12 and 24

  12 and 24 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Four 100mg Etravirine tablets plus one Efavirenz (EFV) placebo tablet once daily

Drug: Etravirine

Group 2

ACTIVE COMPARATOR

One 600mg EFV tablet plus four Etravirine placebo tablet tablets once daily

Drug: Efavirenz

Interventions

Etravirine DRUG

Four 100mg tablets daily for 12-24 weeks

Also known as: TMC125, Brand Name: Intelence

Group 1

Efavirenz DRUG

One 600mg tablet daily

Also known as: TMC125, Brand Name: Intelence

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV-1 infection
• Willing to comply with the protocol requirements
• Has an HIV-plasma viral load at screening \<50 HIV-1 RNA copies/mL
• Has a CD4 cell count at screening \>50 cells/mm3
• Has been on a stable ART, with at least 3 licensed agents, one of which being EFV, for at least 12 weeks at screening, and is willing to stay on treatment until baseline
• Symptomatic toxicity associated with the EFV after at least 12 weeks of therapy
• If subject is female of childbearing potential, she is using effective birth control methods and is 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 ARV's)
• If the subject is a heterosexually active male, he is using effective birth control methods and is willing to continue practicing these birth control methods during the trial and until 30 days after the end of the trial (or after the last intake of investigational ARVs)

You may not qualify if:

• Subject has a primary HIV-1 infection
• Subject has an HIV-2 infection
• Subject is using any concomitant therapy disallowed by the protocol (as per SPC for EFV and TMC125)
• Subject has any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol
• Subject's life expectancy less than 6 months according to the judgment of the investigator
• subject has a currently active AIDS defining illness (Category C conditions according to the Center for Disease Control \[CDC\] Classification System for HIV Infection 1993) with the following exceptions, which must be discussed with the sponsor prior to enrollment:
• Stable cutaneous Kaposi's Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period
• Wasting syndrome due to HIV infection Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed if the medication used is not part of the disallowed medication
• Subject has any active clinically significant disease (e.g., pancreatic, cardiac dysfunction) or findings during Screening of medical history or physical examination that, in the investigator's opinion, would compromise the outcome of the trial

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9TH, United Kingdom

Location

MeSH Terms

Interventions

etravirine; efavirenz

Study Officials

• Mark Nelson

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 18, 2009

Record last verified: 2009-11

Locations

GB (1)