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The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)

This study has been completed.
Sponsor:
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

February 28, 2008
May 23, 2013
March 2008
March 2011   (final data collection date for primary outcome measure)
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
Viral RNA decay characteristics in plasma as determined by an ultrasensitive HIV RNA PCR with a limit of detection of 0.4 copies/ml. The decay curves will be compared between the two treatment groups. [ Time Frame: Plasma viral RNA will be measured twice a week for the first 4 weeks then at two weekly intervals until Week 12 then at four weekly intervals until Week 24, then at 8 weekly intervals until Week 40 with a final visit at Week 52. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00641641 on ClinicalTrials.gov Archive Site
Not Provided
  • To assess the absolute levels and decay characteristics of: 1. Total HIV DNA in peripheral blood mononuclear cells (PBMC). [ Time Frame: 4 times within 52 weeks ] [ Designated as safety issue: Yes ]
  • To assess the absolute levels and decay characteristics of: 2. Total HIV DNA in CD4+ T lymphocytes. [ Time Frame: 4 times within 52 weeks ] [ Designated as safety issue: Yes ]
  • To assess the absolute levels and decay characteristics of: 3. Integrated HIV DNA in PBMC and CD4+ T lymphocytes (Week 0, 12, 24 and 52). [ Time Frame: 20 times within 52 weeks ] [ Designated as safety issue: Yes ]
  • To assess the absolute levels and decay characteristics of: 4. Episomal HIV DNA in PBMC and CD4+ T lymphocytes. [ Time Frame: 20 times within 52 weeks ] [ Designated as safety issue: Yes ]
  • To assess the absolute levels and decay characteristics of: 5. Total DNA, integrated and episomal DNA in resting CD4+ T cells (CD3+, CD4+, CD69-, CD25-, HLADR-). [ Time Frame: 20 times within 52 weeks ] [ Designated as safety issue: Yes ]
  • To assess the absolute levels and decay characteristics of: 6. Total HIV DNA in CD4+ T lymphocytes in lymphoid tissue. (Week 0 and 52) [ Time Frame: 2 times within 52 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: Tenofovir + emtricitabine + raltegravir.
TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.
Other Names:
  • TDF
  • FTC
  • RAL
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.
Intervention: Drug: Tenofovir + emtricitabine + raltegravir.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00641641
PINT01
Yes
CSajjadi, Kirby Institute
Kirby Institute
Merck Sharp & Dohme Corp.
Principal Investigator: Anthony Kelleher, MBBS (Hons) PhD, FRACP, FRCPA Kirby Institute
Kirby Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP