HIV InfectionPINTNCT00641641
The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection
A study testing Tenofovir + emtricitabine + raltegravir. in people with HIV Infection, run by Kirby Institute at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Tenofovir + emtricitabine + raltegravir.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesAustralia
- Study dates
- Mar 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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:
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
St Vincent's Hospital
Darlinghurst, Sydney, New South Wales, 2010
407 Doctors
Sydney, New South Wales, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Taylor Square Private Clinic
Sydney, New South Wales, 2010
About this study
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
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- Tenofovir + emtricitabine + raltegravir.
- Keywords
- Viral compartments, integrase inhibitor therapy, viral species
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir + emtricitabine + raltegravir.Drug
Also called TDF, FTC, RAL
TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tenofovir + emtricitabine + raltegravir. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
change was calculated as the mean of 12 assessments minus the baseline value
Measured: 12 times within 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sally Hough, Kirby Institute
- Investigators
- Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641641
- Sponsor's protocol ID
- PINT01
- Acronym
- PINT
- Status last verified
- Aug 2017
- First submitted
- 28 Feb 2008
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 21860347Murray 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.
PubMed 22410637Hey-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.
PubMed 25730509
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00641641
- Acronym / sponsor ID
- PINT / PINT01
- Conditions
- HIV Infection
- Keywords
- Viral compartments, integrase inhibitor therapy, viral species
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antiretroviral therapy | Experimental | Drug: Tenofovir + emtricitabine + raltegravir.tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
- Documented genotypic (IAS 2007) resistance to tenofovir or emtricitabine from any HIV drug resistance test.
- Any medications contraindicated with Truvada or raltegravir.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir + emtricitabine + raltegravir.Also: TDF, FTC, RALTDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily. | Drug | antiretroviral therapy |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21860347Koelsch 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.
- Results publication: PubMed 22410637Murray 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.
- Derived from this study: PubMed 25730509Hey-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.
- Peer reviewed publication of trial resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA principal investigator
Kirby Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir + emtricitabine + raltegravir. in people with HIV Infection, run by Kirby Institute at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) (time frame: 12 times within 48 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.