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

NCT01061957 | Completed DMC

• 1 other identifier: 37593
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Treatment outcome; HIV treatment

Outcome Measures

Primary Outcomes (1)

• virological suppression and CD4 cell gain

  3,5 years

Secondary Outcomes (1)

• Time to first change of initial regimen.

  3,5 years

Study Arms (2)

Raltegravir patients

HIV patients who initiated raltegravir due to virological failure

Haart naive patients

HIV patients initiating HAART for the first time

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Raltegravir cohort patients: From the Danish HIV Cohort Study (DHCS) we included all HIV-1 positive patients, who
• started raltegravir after 1 January 2006 and before 1 July 2009,
• had been treated with HAART previously
• had at least two VL tests done prior to initiation of raltegravir treatment,
• had virological failure prior to start of raltegravir and
• 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).

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

The Danish HIV Cohort Study, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 4, 2010

Record last verified: 2010-01

Locations

DK (1)