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

NCT01048671 | Completed Results DMC

• 2 other identifiers: 0518-138MK0518-138
• Study Type: observational
• Target: 482
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants

  Baseline and 24 months after start of raltegravir treatment

• 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

Secondary Outcomes (1)

• Number of Participants With at Least One Adverse Event

  Up to 25 months after start of raltegravir treatment

Study Arms (1)

Antiretroviral combination therapy including 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.

Drug: Raltegravir; Drug: ARV (non-raltegravir)

Interventions

Raltegravir DRUG

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.

Also known as: Isentress

Antiretroviral combination therapy including raltegravir

ARV (non-raltegravir) DRUG

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.

Antiretroviral combination therapy including raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant Infected With HIV-1

You may qualify if:

• Participant Infected With HIV-1.
• Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

You may not qualify if:

• Participant taking part in a clinical trial to assess raltegravir.
• Participant in whom raltegravir treatment was started more than 30 days ago.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

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

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 30, 2015
• Results First Posted: February 14, 2014

Record last verified: 2015-10