The First Failure Study

HIV Infections Clinical Trial

— FAST  

Official title:

A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01118871
• Other study ID #: FAST1.0
• Status: Terminated
• Phase: Phase 4
• First received: May 6, 2010
• Last updated: March 23, 2015
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2010
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at two different antiretroviral treatment options in individuals who are about to commence their second antiretroviral treatment.

This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences include: differences in body fat distribution, in lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking to show differences in body fat distribution between the two study treatment arms. Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive function will also be assessed. There is also a lumbar puncture sub study participants can also take part in.

The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years) plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64, 80 and 96)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV-1 infected males or females

• over 18 years of age

• signed informed consent

• currently receiving a stable antiretroviral regimen comprising of:

• two or more licensed NRTIs

• one licensed NNRTI or boosted protease inhibitor

• no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing

• failure of current antiretroviral regimen due to:

• toxicity, intolerance or virological failure if receiving an NNRTI containing regimen at screening

• toxicity or intolerance if receiving a boosted-protease inhibitor regimen at screening (with plasma HIV RNA < 400 copies/mL at screening)

• willing to modify antiretroviral therapy, in accordance with the randomisation assignment

• no previous exposure to etravirine

• subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator

• have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen

• female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study:

• barrier contraceptives (condom, diaphragm with spermicide)

• IUD or Depo PLUS a barrier contraceptive

• female subjects of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

• current alcohol abuse or drug dependence

• pregnancy

• active opportunistic infection or significant co-morbidities

• current prohibited concomitant medication

• a likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• Darunavir, Ritonavir, Truvada
Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
• Darunavir, Ritonavir and Etravirine
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily

Locations

Country	Name	City	State
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in peripheral and central adipose tissue	As measured by DEXA, between treatment arms.	week 48 and 96	No
Secondary	Percentage of patients <50 copies HIV-1 RNA/mL	At all study points to weeks 48 and 96 between treatment arms.	96 weeks	No
Secondary	Mean change from baseline of absolute CD4+ T cell count	between treatment arms	96 weeks	No
Secondary	Time to change in randomly assigned therapy	between treatment arms	96 weeks	No
Secondary	Mean change from baseline Lipodystrophy Case Definition score	Between treatment arms	96 weeks	No
Secondary	Mean change from baseline in fasting lipid and glycaemia parameters	between treatment arms	96 weeks	Yes
Secondary	Mean change from baseline in cardiac and bone biomarker levels	between treatment arms	Week 96	Yes
Secondary	• Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs	Between the treatment arms	96 week s	Yes
Secondary	Patterns of genotypic HIV resistance associated with virological treatment failure	Across the treatment arms	96 weeks	No
Secondary	Describe aspects of immune reconstitution disease (IRD)	Across the treatment arms	96 weeks	Yes
Secondary	Comparison of quality of life and results of adherence questionnaires	Between the treatment arms	96 weeks	No