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Completed

NCT Number: NCT01048671

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

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

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Isentress

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.

Primary outcomes

  1. Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir

    Time frame: Up to 25 months after start of raltegravir treatment

    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.

  2. Percentage of Participants Responding to Treatment: All Treated Participants

    Time frame: 24 months after start of raltegravir treatment

    Response to treatment was defined as a viral load <50 RNA copies/mL

  3. Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24

    Time frame: 24 months after start of raltegravir treatment

    Response to treatment was defined as a viral load <50 RNA copies/mL

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

    Time frame: Baseline and 24 months after start of raltegravir treatment

  5. Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24

    Time frame: Baseline and 24 months after start of raltegravir treatment

Secondary outcomes

  1. Number of Participants With at Least One Adverse Event

    Time frame: Up to 25 months after start of raltegravir treatment

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: RACING

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2010
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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