Raltegravir Treatment in Patients Failing Highly Active Antiretroviral Therapy (HAART) in Denmark
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ClinicalTrials.gov Identifier: NCT01061957 |
Recruitment Status
:
Completed
First Posted
: February 3, 2010
Last Update Posted
: February 4, 2010
|
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Condition or disease |
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HIV Infections |
Study Type : | Observational |
Actual Enrollment : | 96 participants |
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. |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | December 2009 |

Group/Cohort |
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Raltegravir patients
HIV patients who initiated raltegravir due to virological failure
|
Haart naive patients
HIV patients initiating HAART for the first time
|
- virological suppression and CD4 cell gain [ Time Frame: 3,5 years ]
- Time to first change of initial regimen. [ Time Frame: 3,5 years ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
-
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).

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 ClinicalTrials.gov identifier (NCT number): NCT01061957
Denmark | |
The Danish HIV Cohort Study, Rigshospitalet | |
Copenhagen, Denmark, 2100 |
Responsible Party: | Jan Gerstoft, MD, Professor, The Danish HIV Cohort Study |
ClinicalTrials.gov Identifier: | NCT01061957 History of Changes |
Other Study ID Numbers: |
37593 |
First Posted: | February 3, 2010 Key Record Dates |
Last Update Posted: | February 4, 2010 |
Last Verified: | January 2010 |
Keywords provided by Rigshospitalet, Denmark:
Treatment outcome HIV treatment |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |