The First Failure Study

NCT01118871 | Terminated Phase 4

• 1 other identifier: FAST1.0
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

HIV; HIV Infections

Keywords

Treatment experienced

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in peripheral and central adipose tissue

  As measured by DEXA, between treatment arms.

  week 48 and 96

Secondary Outcomes (10)

• Percentage of patients <50 copies HIV-1 RNA/mL

  96 weeks

• Mean change from baseline of absolute CD4+ T cell count

  96 weeks

• Time to change in randomly assigned therapy

  96 weeks

• Mean change from baseline Lipodystrophy Case Definition score

  96 weeks

• Mean change from baseline in fasting lipid and glycaemia parameters

  96 weeks

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Drug: Darunavir, Ritonavir, Truvada

NRTI sparing arm

EXPERIMENTAL

Drug: Darunavir, Ritonavir and Etravirine

Interventions

Darunavir, Ritonavir, Truvada DRUG

Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily

Also known as: Prezista, Norvir, Truvada

Standard of care

Darunavir, Ritonavir and Etravirine DRUG

Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily

Also known as: Prezista, Norvir, Intelence

NRTI sparing arm

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 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir; Ritonavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; etravirine

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Alan Winston, MB ChB

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 24, 2015

Record last verified: 2010-07

Locations

GB (1)