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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
CSajjadi, Kirby Institute
ClinicalTrials.gov Identifier:
NCT00641641
First received: February 28, 2008
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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
HIV Infection
Drug: Tenofovir + emtricitabine + raltegravir.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) [ Time Frame: 12 times within 48 weeks. ] [ Designated as safety issue: No ]
    change was calculated as the mean of 12 assessments minus the baseline value


Enrollment: 16
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: CSajjadi, Central Admin, Kirby Institute
ClinicalTrials.gov Identifier: NCT00641641     History of Changes
Other Study ID Numbers: PINT01
Study First Received: February 28, 2008
Results First Received: April 11, 2012
Last Updated: May 23, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
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
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 28, 2014