Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)

HIV Infections Clinical Trial

— RACING  

Official title:

Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048671
• Other study ID #: 0518-138
• Secondary ID: MK0518-138
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: October 29, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant Infected With HIV-1.

• Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.

• Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

Exclusion Criteria:

• Participant taking part in a clinical trial to assess raltegravir.

• Participant in whom raltegravir treatment was started more than 30 days ago.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Raltegravir
Raltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily.
• ARV (non-raltegravir)
ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir	Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.	Up to 25 months after start of raltegravir treatment	No
Primary	Percentage of Participants Responding to Treatment: All Treated Participants	Response to treatment was defined as a viral load <50 RNA copies/mL	24 months after start of raltegravir treatment	No
Primary	Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24	Response to treatment was defined as a viral load <50 RNA copies/mL	24 months after start of raltegravir treatment	No
Primary	Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants		Baseline and 24 months after start of raltegravir treatment	No
Primary	Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24		Baseline and 24 months after start of raltegravir treatment	No
Secondary	Number of Participants With at Least One Adverse Event	An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product.	Up to 25 months after start of raltegravir treatment	Yes