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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00641641

First Posted: March 24, 2008

Last Update Posted: August 31, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Sally Hough, Kirby Institute

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:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Sally Hough, Kirby Institute:

Primary Outcome Measures:

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


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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

Additional Information:

Peer reviewed publication of trial results This link exits the ClinicalTrials.gov site

Publications:

Koelsch KK, Boesecke C, McBride K, Gelgor L, Fahey P, Natarajan V, Baker D, Bloch M, Murray JM, Zaunders J, Emery S, Cooper DA, Kelleher AD; PINT study team. Impact of treatment with raltegravir during primary or chronic HIV infection on RNA decay characteristics and the HIV viral reservoir. AIDS. 2011 Nov 13;25(17):2069-78. doi: 10.1097/QAD.0b013e32834b9658. Erratum in: AIDS. 2012 Nov 28;26(18):2425. AIDS. 2012 Jul 17;26(11):1455.

Murray JM, McBride K, Boesecke C, Bailey M, Amin J, Suzuki K, Baker D, Zaunders JJ, Emery S, Cooper DA, Koelsch KK, Kelleher AD; PINT STUDY TEAM. Integrated HIV DNA accumulates prior to treatment while episomal HIV DNA records ongoing transmission afterwards. AIDS. 2012 Mar 13;26(5):543-50. doi: 10.1097/QAD.0b013e328350fb3c.

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

Hey-Cunningham WJ, Murray JM, Natarajan V, Amin J, Moore CL, Emery S, Cooper DA, Zaunders J, Kelleher AD, Koelsch KK; PINT study team. Early antiretroviral therapy with raltegravir generates sustained reductions in HIV reservoirs but not lower T-cell activation levels. AIDS. 2015 May 15;29(8):911-9. doi: 10.1097/QAD.0000000000000625.


Responsible Party:	Sally Hough, Senior Clinical Project Coordinator, Kirby Institute
ClinicalTrials.gov Identifier:	NCT00641641 History of Changes
Other Study ID Numbers:	PINT01
First Submitted:	February 28, 2008
First Posted:	March 24, 2008
Results First Submitted:	April 11, 2012
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

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