Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 1:29 AM
Study NCT ID:
NCT01061957
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2010-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Raltegravir Treatment in Patients Failing Highly Active Antiretroviral Therapy (HAART) in Denmark
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Clinical, Virological and Immunological Course in Danish Patients With Triple Class Failure Receiving Raltegravir as Part of a Salvage Regimen.
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: