The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)
This study has been completed.
Sponsor:
Kirby Institute
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
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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:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Tenofovir Disoproxil Fumarate
Raltegravir
Raltegravir potassium
U.S. FDA Resources
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:
|
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 (Adult, Senior) |
| 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
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
|
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 |
Raltegravir Potassium Tenofovir Emtricitabine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016