The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)
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ClinicalTrials.gov Identifier: NCT00641641 |
Recruitment Status :
Completed
First Posted : March 24, 2008
Results First Posted : May 27, 2013
Last Update Posted : August 31, 2017
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Condition or disease | Intervention/treatment | Phase |
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HIV Infection | Drug: Tenofovir + emtricitabine + raltegravir. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
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 |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Tenofovir + emtricitabine + raltegravir.
TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.
Other Names:
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

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
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 |
Principal Investigator: | Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA | Kirby Institute |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sally Hough, Senior Clinical Project Coordinator, Kirby Institute |
ClinicalTrials.gov Identifier: | NCT00641641 |
Other Study ID Numbers: |
PINT01 |
First Posted: | March 24, 2008 Key Record Dates |
Results First Posted: | May 27, 2013 |
Last Update Posted: | August 31, 2017 |
Last Verified: | August 2017 |
Viral compartments integrase inhibitor therapy viral species |
Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Tenofovir Emtricitabine Raltegravir Potassium Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents HIV Integrase Inhibitors Integrase Inhibitors |