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Double Protease Inhibitor to Darunavir Switch Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531557
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : August 16, 2010
Information provided by:
St Stephens Aids Trust

Brief Summary:

The purpose of the study is to study the effects of switching from an antiretroviral combination that includes two ritonavir boosted protease inhibitors to replacement of these two protease inhibitors with a new protease inhibitor called Darunavir (also boosted with ritonavir).

The study will investigate the effect of the switch on viral load (the levels of the HIV virus in the blood), on immunological parameters (CD4 count) and on other safety parameters and also on quality of life.

In a subgroup of patients the impact of the switch on the body's response to the hormone insulin will also be measured (Euglycaemic clamp sub group)

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Darunavir ritonavir Phase 4

Detailed Description:

HIV-RNA and CD4+ cell count to monitor virological and immunological response on switching to DRV/r.

Routine safety bloods to include haematology and biochemistry (including U&E, fasted glucose and insulin, liver function test, fasting cholesterol and triglycerides and serum lactate measurements).

Quality of life EuroQOL questionnaires at baseline, and throughout the study to evaluate quality of life in the continued treatment/ treatment switch arms.

A sub group of 10 patients will undergo two euglycaemic clamp procedures in order to determine the extent of glucose disposal. The first clamp will be performed prior to the switching from a double boosted PI therapy to DRV/r and the second one following administration of DRV/r for 4 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase IV Cohort Study Assessing Feasibility of Substituting Double Ritonavir-boosted Protease Inhibitors With Ritonavir-boosted Darunavir in HIV-infected Individuals With Viral Suppression on Highly Active Antiretroviral Therapy.
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Darunavir 600mg BID with ritonavir 100mg BID administered orally.
Drug: Darunavir ritonavir

Primary Outcome Measures :
  1. The proportion of subjects maintaining viral suppression (< 50 copies/mL) [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. • CD4+ count at screening, baseline, weeks 4, 12, 24, 36 and at the end of the study period • Viral suppression below 50 copies/mL and below 500 copies/mL at 4, 12, 24, 36 and 48 weeks • Laboratory abnormalities and adverse events at baseline, 4 [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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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:

  1. HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
  2. At least 18 years of age
  3. Currently on an antiretroviral regimen including a ritonavir boosted double protease inhibitor
  4. The subject is virologically suppressed with a viral load < 50 copies/mL for three months or longer
  5. The subject has a CD4+ count above 100 cells/mL
  6. ≤ Three DRV associated mutations on previous genotypic resistance test -or if no resistance test available, likely to have ≤ four protease inhibitor mutations based on their clinical history
  7. If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception
  8. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Individuals with prior darunavir exposure
  3. Previous allergic or hypersensitivity reaction to darunavir
  4. Clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency)
  5. Subjects diagnosed with acute viral hepatitis at screening
  6. Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table (see appendix 3: DAIDS AE grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject:

    • Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations
    • Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4.
  7. Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: Stable cutaneous Kaposi's Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study; Wasting syndrome due to HIV infection.

    Note: An AIDS defining illness that is not clinically stabilized for at least 30 days will be considered as currently active.

  8. Active drug abuse, including alcohol or recreational drugs, which, in the opinion of the investigator, is expected to interfere with the subject's ability to adhere to the study procedures and treatment regimen. Subjects on a methadone program will be accepted if deemed appropriate by the investigator.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00531557

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United Kingdom
St Stephens Centre, Chelsea & Westminster Hospital
London, United Kingdom
Sponsors and Collaborators
St Stephens Aids Trust
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Principal Investigator: Mark Nelson Chelsea & Westminser Healthcare NHS Trust
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Responsible Party: Dr Mark Nelson, St Stephens Aids Trust Identifier: NCT00531557    
Other Study ID Numbers: SSAT022
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010
Keywords provided by St Stephens Aids Trust:
Euglycaemic clamp
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors