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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00641641




Registration number
NCT00641641
Ethics application status
Date submitted
28/02/2008
Date registered
24/03/2008
Date last updated
31/08/2017

Titles & IDs
Public title
The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection
Scientific 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
Secondary ID [1] 0 0
PINT01
Universal Trial Number (UTN)
Trial acronym
PINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenofovir + emtricitabine + raltegravir.

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.


Treatment: Drugs: Tenofovir + emtricitabine + raltegravir.
TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) - change was calculated as the mean of 12 assessments minus the baseline value
Timepoint [1] 0 0
12 times within 48 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst, Sydney
Recruitment hospital [2] 0 0
407 Doctors - Sydney
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
Taylor Square Private Clinic - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00641641
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications