Raltegravir Treatment in Patients Failing Highly Active Antiretroviral Therapy (HAART) in Denmark

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
First received: February 2, 2010
Last updated: February 3, 2010
Last verified: January 2010
Raltegravir is the first integrase inhibitor approved for treatment of HIV infected patients harboring multiresistant viruses. The drug has been proved effective in both trials and clinical settings, but the long-term efficacy is not described and the effect compared to treatment in Highly active antiretroviral therapy (HAART) naive patients remains to be established.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical, Virological and Immunological Course in Danish Patients With Triple Class Failure Receiving Raltegravir as Part of a Salvage Regimen.

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • virological suppression and CD4 cell gain [ Time Frame: 3,5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first change of initial regimen. [ Time Frame: 3,5 years ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Raltegravir patients
HIV patients who initiated raltegravir due to virological failure
Haart naive patients
HIV patients initiating HAART for the first time

Detailed Description:
Highly active antiretroviral therapy (HAART) was introduced more than a decade ago and the therapy has decreased mortality and morbidity of HIV patients dramatically. The first HAART regimens were combined of nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). Especially the early regimes carried a substantial risk of failure and subsequent development of resistance to the three drug classes. Thus there has been a need for development of new drugs with activity against viruses resistant to the classical HAART regimens either as new drugs from the old classes without (or with limited) cross resistance to the older compounds or drugs from new classes with new antiretroviral mechanisms. The optimal choice for salvage therapy for HIV infected patients has been shown to require at least two, and preferably three, fully active drugs. Until recently, salvage regimens used to treat patients harbouring multidrug-resistant HIV generally included only one new agent from the classic drug classes added to an optimized background therapy which did not contain any fully active agents. This approach, conditioned by limited drug options, put patients at high risk of virological failure and resistance to the new agent, as well as to other agents in the same drug classes. A breakthrough has been the resent development of integrase inhibitors, which is a new class of antiretroviral drugs. One of these drugs - raltegravir - has demonstrated its activity in patients with virological failure on classical antiretroviral drugs. In the BENCHMARK randomized clinical trials, which were conducted in HIV-infected patients with limited treatment options, 62% of patients taking raltegravir plus optimized background treatment achieved plasma HIV RNA levels <50 copies/mL at week 48. Although the drug - often used together with other new drugs - has been proved effective in clinical trials and recently in "real life" clinical settings, the long-term efficacy is not described and the effect compared to treatment in HAART naive patients remains to be established. In a nationwide cohort of HIV infected patients, we identified the patients, who initiated raltegravir due to virological failure and a matched control cohort of patients initiating HAART for the first time. We compared these two cohorts with respect to virological suppression, gain in CD4 count and time to first change of initial regimen.

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One cohort of HIV patients with virological failure initiating Raltegravir One control cohort of HIV patients initiating HAART for the first time.

Inclusion Criteria:

  • Raltegravir cohort patients: From the Danish HIV Cohort Study (DHCS) we included all HIV-1 positive patients, who

    1. started raltegravir after 1 January 2006 and before 1 July 2009,
    2. had been treated with HAART previously
    3. had at least two VL tests done prior to initiation of raltegravir treatment,
    4. had virological failure prior to start of raltegravir and
    5. did not participate in randomized clinical trials on raltegravir. Virological failure was defined as VL > 500 copies/ml in the two latest VL tests prior to raltegravir initiation while on HAART treatment.
  • Control cohort patients: From DHCS we identified a control cohort of HIV infected patients who started HAART for the first time after 1 January 2006 and before 1 July 2009. From this population we extracted two control patients for each raltegravir patient, each matched by gender, race (Caucasian, Black and other), route of HIV infection (homosexual, heterosexual, injection drug user (IDU) and other) and age (intervals of < 20 years, 20 to 30 years, 30 to 40 years, > 50 years).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01061957

The Danish HIV Cohort Study, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Jan Gerstoft, MD, Professor, The Danish HIV Cohort Study
ClinicalTrials.gov Identifier: NCT01061957     History of Changes
Other Study ID Numbers: 37593 
Study First Received: February 2, 2010
Last Updated: February 3, 2010
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Treatment outcome
HIV treatment

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016