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

NCT00641641 | Completed Results DMC

• 1 other identifier: PINT01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infection

Keywords

Viral compartments; integrase inhibitor therapy; viral species

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)

  change was calculated as the mean of 12 assessments minus the baseline value

  12 times within 48 weeks.

Study Arms (1)

antiretroviral therapy

EXPERIMENTAL

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.

Interventions

Tenofovir + emtricitabine + raltegravir. DRUG

TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.

Also known as: TDF, FTC, RAL

antiretroviral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirby Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

St Vincent's Hospital

Darlinghurst, Sydney, New South Wales, 2010, Australia

Location

407 Doctors

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Sydney, New South Wales, 2010, Australia

Location

Related Publications (3)

• 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.

  PMID: 21860347 RESULT

• 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.

  PMID: 22410637 RESULT

• 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.

  PMID: 25730509 DERIVED

Related Links

• Peer reviewed publication of trial results

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyrrolidinones; Pyrrolidines

Limitations and Caveats

Limited cohort (n=16) of exclusively male participants treated with a licensed regimen of combination antiretroviral therapy with the primary focus being a detailed examination of virus decay characteristics

Results Point of Contact

• Title: Sean Emery
• Organization: University of New South Wales

semery@kirby.unsw.edu.au

9385 0900

Study Officials

• Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Project Coordinator

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 24, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 31, 2017
• Results First Posted: May 27, 2013

Record last verified: 2017-08

Locations

AU (4)