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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Kirby Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00641641
First received: February 28, 2008
Last updated: March 31, 2009
Last verified: March 2009
History of Changes
  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
Primary HIV (Acute or Early)
Chronic HIV Infection
 Drug: Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Viral RNA decay characteristics in plasma as determined by an ultrasensitive HIV RNA PCR with a limit of detection of 0.4 copies/ml. The decay curves will be compared between the two treatment groups. [ Time Frame: 24 times within 156 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the absolute levels and decay characteristics of: 1. Total HIV DNA in peripheral blood mononuclear cells (PBMC). [ Time Frame: 24 times within 156 weeks ] [ Designated as safety issue: No ]
  • To assess the absolute levels and decay characteristics of: 2. Total HIV DNA in CD4+ T lymphocytes. [ Time Frame: 24 times within 156 weeks ] [ Designated as safety issue: No ]
  • To assess the absolute levels and decay characteristics of: 3. Integrated HIV DNA in PBMC and CD4+ T lymphocytes. [ Time Frame: 8 times within 156 weeks ] [ Designated as safety issue: No ]
  • To assess the absolute levels and decay characteristics of: 4. Episomal HIV DNA in PBMC and CD4+ T lymphocytes. [ Time Frame: 8 times within 156 weeks ] [ Designated as safety issue: No ]
  • To assess the absolute levels and decay characteristics of: 5. Total DNA, integrated and episomal DNA in resting CD4+ T cells (CD3+, CD4+, CD69-, CD25-, HLADR-). [ Time Frame: 8 times within 156 weeks ] [ Designated as safety issue: No ]
  • To assess the absolute levels and decay characteristics of: 6. Total HIV DNA in CD4+ T lymphocytes in lymphoid tissue. (Week 0 and 52) [ Time Frame: 3 times within 156 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug intervention
Drug intervention
 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).
Other Names:
  • TDF/FTC
  • Truvada

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
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
Investigators
Principal Investigator: Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA Kirby Institute
  More Information

No publications provided by Kirby Institute

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

Responsible Party: Associate Professor Anthony Kelleher, National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier: NCT00641641     History of Changes
Other Study ID Numbers: PINT01
Study First Received: February 28, 2008
Last Updated: March 31, 2009
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
Integrase Inhibitors
Tenofovir
 Tenofovir disoproxil
Emtricitabine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013