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Sponsors and Collaborators: |
The National Centre in HIV Epidemiology and Clinical Research Merck Sharp and Dohme |
Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00641641 |
The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
Condition | Intervention |
Primary HIV (Acute or Early) Chronic HIV Infection |
Drug: Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Raltegravir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Examine the Characteristics of HIV Decay Following Introduction of Combination Antiretroviral Therapy Including Raltegravir During Primary and Chronic HIV Infection |
Estimated Enrollment: | 16 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Drug intervention: Experimental
Drug intervention
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Drug: Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir.
At Day 0, subjects will be required to start treatment consisting of Truvada (FTC 200mg + TDF 300mg once daily) plus raltegravir (400mg twice daily).
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The study is an open-label study of 1-year duration. This study will be conducted at 5 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. Subjects will be followed for one year with intensive quantification of both plasma RNA and cell associated DNA viral species.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Cohort A: Primary HIV infection:
Documented acute or early infection diagnosed by:
Acute infection:
< 3 bands on Western Blot and any one of: i. positive p24 antigen ii. positive proviral DNA
Early infection:
i. Positive detuned or BED ELISA result OR ii. Previously negative serology within 6 months of confirmed positive serology.
Cohort B: Chronic HIV infection:
Documented HIV-infection of at least 12 months duration.
Exclusion Criteria:
Receipt of any of the following within 6 months of study entry:
Contact: Christoph Boesecke, MD | +61293850900 | cboesecke@nchecr.unsw.edu.au |
Contact: Sean Emery, BSc (hons) PhD | +61293850900 | semery@nchecr.unsw.edu.au |
Australia, New South Wales | |||||
St Vincent's Hospital | |||||
Darlinghurst, Sydney, New South Wales, Australia, 2010 | |||||
Principal Investigator: Anthony Kelleher, MBBS (Hons) PhD FRACP FRCPA | |||||
407 Doctors | Not yet recruiting | ||||
Sydney, New South Wales, Australia, 2010 | |||||
Contact: Robyn Vale (61) 2 9332 2531 robynv@407.com.au | |||||
Principal Investigator: David Baker, MB ChB | |||||
AIDS Research Initiative | |||||
Sydney, New South Wales, Australia, 2010 | |||||
Contact: Vanessa Rees +61 2 9360-7172 vrees@aids-research.com.au | |||||
Principal Investigator: Cassy Workman, MD | |||||
Holdsworth House Medical Practice | Not yet recruiting | ||||
Sydney, New South Wales, Australia, 2010 | |||||
Contact: Nicky Cunnigham +61 (02) 9331-7822 nickycunningham@holdsworthhouse.com.au | |||||
Contact: Kate Beileiter +61 (02) 9331-7822 kbeileiter@holdsworthhouse.com.au | |||||
Principal Investigator: Mark Bloch, MB BS | |||||
Taylor Square Private Clinic | |||||
Sydney, New South Wales, Australia, 2010 | |||||
Contact: Sophie Dinning +61 2 9331-6151 sdinning@tspc.com.au | |||||
Contact: Robyn Richardson +61 2 9331-6151 robynr@medemail.com.au | |||||
Principal Investigator: Robert Finlayson, MD |
The National Centre in HIV Epidemiology and Clinical Research |
Merck Sharp and Dohme |
Principal Investigator: | Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA | The National Centre in HIV Epidemiology and Clinical Research |
Responsible Party: | National Centre in HIV Epidemiology and Clinical Research ( Associate Professor Anthony Kelleher ) |
Study ID Numbers: | PINT01 |
First Received: | February 28, 2008 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00641641 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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