Overview

A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
Summary
This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Raltegravir Potassium
Criteria
Inclusion Criteria

The prospective participant must meet, at least, all of the criteria below to be eligible
for study participation. The participant:

- Is a minimum age of 18 years (adults) or 50 years (aging participants);

- Is male or female;

- Has confirmed infection with HIV-1 (positive HIV test according to appropriate
standard practice);

- Has commenced antiretroviral treatment with Raltegravir according to the
recommendations made in the Summary of Product Characteristics at the time of
enrollment on the study, or a maximum 6 months prior to enrollment on the study;

- Has any cluster of differentiation (CD4) cell (specialized white blood cell) count
upon enrollment on the study.

Exclusion criteria

If the prospective participant meets any of the criteria below (among others determined by
the study staff) they will NOT be eligible for study participation. The participant:

- For which Raltegravir, or its ingredients, are contraindicated;

- Has intolerance to Raltegravir, or its ingredients;

- If female, is pregnant, breastfeeding, or is planning a pregnancy or egg donation
during the study.