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The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)

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ClinicalTrials.gov Identifier: NCT00641641
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : May 27, 2013
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sally Hough, Kirby Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Drug: Tenofovir + emtricitabine + raltegravir. Not Applicable

Detailed Description:
The study is an open-label study of 3-years duration. This study will be conducted at 4 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 three years with intensive quantification of both plasma RNA and cell associated DNA viral species.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: antiretroviral therapy
tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day.
 Drug: Tenofovir + emtricitabine + raltegravir.
TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.
Other Names:
  • TDF
  • FTC
  • RAL


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) [ Time Frame: 12 times within 48 weeks. ]
    change was calculated as the mean of 12 assessments minus the baseline value


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18 years.
  • Provision of written, informed consent.
  • Screening plasma HIV RNA > 10,000 copies/mL.
  • Screening CD4+ T lymphocyte count > 100 x 10^6)/L.
  • No previous antiretroviral therapy.
  • Haemoglobin > 115 g/L (female) or > 130 g/L (male).
  • Absolute neutrophil count > 1 x 10^9/L.
  • Platelet count > 100 x 10^9/L
  • Serum bilirubin < 1.5 x ULN.
  • Serum alkaline phosphatase < 3 X ULN.
  • Serum aspartate aminotransferase (AST) < 3 X ULN.
  • Serum alanine aminotransferase (ALT) < 3 X ULN.
  • Creatinine clearance > 50mL/min (Creatinine clearance (mL/min) =140 - age x weight creatinine Multiply the result by 1.2 for men).

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:

  • Pregnancy or breastfeeding.
  • Receipt of investigational products within 1 month of study entry.

  • Receipt of any of the following within 6 months of study entry:

    • interferon alpha or gamma
    • oral corticosteroids (inhaled or topical corticosteroids are permitted)
    • cyclosporin
    • alkylating agents
    • other immunosuppressive agents
    • rifampin
    • phenytoin
    • phenobarbital
  • Documented genotypic (IAS 2007) resistance to tenofovir or emtricitabine from any HIV drug resistance test.
  • Any medications contraindicated with Truvada or raltegravir.
  • Significant intercurrent illnesses apart from HIV infection such as viral hepatitis (diagnosed by core hepatitis B antigen and/or positive hepatitis B PCR or positive hepatitis C PCR) or any other condition which in the opinion of the investigator would compromise participation in the study.
  • History of non-traumatic osteoporotic fracture.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641641


Locations
Australia, New South Wales
St Vincent's Hospital
Darlinghurst, Sydney, New South Wales, Australia, 2010
407 Doctors
Sydney, New South Wales, Australia, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
Kirby Institute
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA Kirby Institute
More Information
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Additional Information:
Peer reviewed publication of trial results  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sally Hough, Senior Clinical Project Coordinator, Kirby Institute
ClinicalTrials.gov Identifier: NCT00641641     History of Changes
Other Study ID Numbers: PINT01
First Posted: March 24, 2008    Key Record Dates
Results First Posted: May 27, 2013
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Sally Hough, Kirby Institute:
Viral compartments
integrase inhibitor therapy
viral species

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Tenofovir
Raltegravir Potassium
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors