Status:
COMPLETED
The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 integras...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00641641
Start Date
March 1 2008
End Date
June 1 2011
Last Update
August 31 2017
Active Locations (4)
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1
St Vincent's Hospital
Darlinghurst, Sydney, New South Wales, Australia, 2010
2
407 Doctors
Sydney, New South Wales, Australia, 2010
3
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
4
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010