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Clinical trials database - closed trials

Closed clinical trials in the NAPWA database are listed below – the most recently-added entries are shown at the top of the list.

(‘Closed’ clinical trials include those listed as fully enrolled, concluded, or cancelled.)

Immune responses to hepatitis B

Clinical trial • Unknown • 19 February 2010

Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
Tags: hepatitis B

CMV and interferon

Clinical trial • Unknown • 17 February 2010

Evaluation of Interferon-Gamma Responses to HCMV Infection in HIV Positive Individuals
Tags: CMV

'Naive T-cell' study

Clinical trial • Unknown • 17 February 2010

Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV
Tags: newly diagnosed, pathogenesis, primary HIV infection

GB Virus C, HIV and HCV

Clinical trial • Reported • 17 February 2010

Associations, Outcomes and Genomics of GB Virus C, Hepatitis C Virus and Human Immunodeficiency Virus Infection

AVX-754

Clinical trial • Concluded • 17 February 2010

A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase
Tags: drug resistance, NRTI

Expanded Access Program for Maraviroc at Multiple Centres

Clinical trial • No longer enrolling • 29 April 2008

A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc
Tags: maraviroc

STEP HIV vaccine study

Clinical trial • Cancelled • 10 May 2007

A multicentre, Double-Blind, Randomised, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype-5 HIV-1 Vaccine gag/pol/nef (MRKad5 HIV-1 gag/pol/nef in Adults at High Risk of HIV-1 Infection
Tags: preventative vaccines, Safe sex

TMC114 (darunavir)

Clinical trial • Concluded • 5 May 2008

A Randomized, Open-Label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-Experienced HIV-1 Infected Subjects.
Tags: darunavir, optimised background regimens

Elvitegravir versus raltegravir

Clinical trial • No longer enrolling • 22 October 2008

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults
Tags: Elvitegravir, integrase inhibitor, raltegravir

Bevirimat monotherapy

Clinical trial • No longer enrolling • 8 April 2009

A Phase II multicenter, open-label, randomized, parallel group, study of bevirimat (MPC-4326) in HIV-1 positive patients to evaluate the safety, efficacy, and pharmacokinetics of bevirimat administered as monotherapy for 14 days and as part of an optimized background regimen for up to 72 weeks.
Tags: Bevirimat

NGX-4010 (neuropathy treatment)

Clinical trial • Reported • 11 May 2007

A Multicentre randomized, double-blind, controlled study of NGX-4010 for the treatment of painful HIV-Associated Neuropathy
Tags: peripheral neuropathy, treatment side effects

AVX-201E (apricitabine) extension study

Clinical trial • Concluded • 11 May 2007

An open-label extension study to evaluate the long-term safety and efficacy of apricitabine in controlling Human Immunodeficiency Virus (HIV) viral load and disease progression in treatment-experienced HIV-1 infected subjects

TEddI (adherence)

Clinical trial • Reported • 16 April 2008

A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine, Efavirenz and Didanosine Versus Continuation of Current Anti-Retroviral Regimen Delivered at Least Twice Daily
Tags: adherance

Apricitabine (AVX-301)

Clinical trial • No longer enrolling • 11 April 2008

A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase
Tags: Apricitabine, NRTI

Intensification study (raltegravir and bovine colostrum) CORAL

Clinical trial • No longer enrolling • 26 February 2008

A randomized, double-blind, placebo controlled multi-centre study to measure the effect on CD4+ outcomes of combination antiretroviral therapy (cART) intensification with or without passive immunotherapy to reduce immune activation in HIV infected individuals with persistent CD4+ T-cell count of less than 350 cells despite prolonged HIV plasma viraemia of less than 50 copies for at least 12 months on combination antiretroviral therapy.

ALTAIR (Truvada for treatment-naive)

Clinical trial • No longer enrolling • 11 May 2007

A Randomised Open-Label Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection
Tags: first-line therapy, starting treatments

TMC278 (rilpivirine) versus efavirenz (2 trials)

Clinical trial • Fully enrolled • 22 October 2008

A Phase III, Randomized, Double-Blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Naive HIV-1 Infected Subjects >>>>> AND <<<< A Phase III, Randomized, Double-Blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-Naive HIV-1 Infected Subjects.

ATAHC: Australian trial in acute hepatitis C

Clinical trial • Concluded • 29 April 2008

Australian Trial in Acute Hepatitis C
Tags: hepatitis C, liver disorders

CASTLE (atazanavir versus lopinavir)

Clinical trial • Reported • 11 April 2008

A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects

TMC125 (etravirine) for people who failed on the DUET studies

Clinical trial • Concluded • 10 May 2007

An Open-Label Trial with TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216)

Nevirapine toxicogenomics study

Clinical trial • Concluded • 28 March 2008

A Case and Control Toxicogenomics Study to Identify Genetic Locus or Loci in Patients Who Have Experienced Symptomatic Hepatotoxicity and Severe Skin Reactions Within the First 8 Weeks of Nevirapine Therapy
Tags: hepatotoxicity, liver disorders, treatment side effects

RESIST (tipranavir)

Clinical trial • Reported • 28 March 2008

Randomized, Open-Label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-Dose Ritonavir (TPV/RTV) Verses Genotypically-Defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-Experienced Patients

Rollover Tipranavir and Ritonavir Trial

Clinical trial • Reported • 28 March 2008

A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
Tags: optimised background regimens

DUET study (etravirine)

Clinical trial • Reported • 10 May 2007

A Phase III Randomised, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as part of an ART Regimen, Including TMC114/RTV and an Investigator-Selected OBR, in HIV-1 Infected Patients with Limited Treatment to No Treatment Options
Tags: etravirine, NNRTI, optimised background regimens TMC-125

The SMART Study

Clinical trial • Cancelled • 14 November 2008

A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Tags: SMART, treatment interruption