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A5244 - A Double-blind, Randomized, Pilot Study to Measure the Effect of Treatment Intensification with a Potent Integrase Inhibitor, Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia below 50 copies/mL in Subjects on Protease Inhibitor- or Nonnucleoside Reverse Transcriptase Inhibitor-Containing Regimens
A study to test whether adding a new investigational HIV drug, Raltegravir, to standard therapy reduces the amount of HIV in the blood.
(All study information from A5244 Participant Information Sheet.)

Eligible candidates:

  • HIV-1 infected people at least 18 years of age
  • Had a viral load of >100,000 copies/ml before starting any HIV medication
  • Have undetectable viral load for at least 6 months while on HIV medications
  • Have been on HIV medication for at least 12 months, and have not changed medication in 3 months
  • Have a CD4+ count >200
  • Other requirements will be discussed by the study nurse or doctor

Study Objective:
This study aims to find out if adding raltegravir reduces the amount of HIV in the blood using a test that measures very low amounts of the virus.
Raltegravir is a new drug that blocks HIV in a different way than current HIV medicines. This study will focus on HIV-infected people who have “undetectable” viral load. Most people who are told that they have “undetectable” viral loads still have HIV that can be measured in their blood using a sensitive test called the single copy assay (SCA). This is because regular viral load tests only measure down to 50 copies of HIV in each cc of blood whereas the SCA measures down to 1 copy in each cc of blood. In this study we will measure the amount of HIV in your blood using the SCA before and after you add raltegravir to your current HIV medicines. We are also trying to find out if adding raltegravir to your HIV medicine causes any side effects or problems. If raltegravir lowers the amount of HIV in your blood, this may lead to other studies on how to prevent HIV from persisting in people with the infection.

Study Scheme:
All people who enroll in this study will add raltegravir to their current HIV medicines: half of the people add raltegravir for the 1st 12 weeks, and then take placebo for 12 more weeks; half add placebo for the first 12 weeks and then take raltegravir for 12 more weeks. All patients continue their current HIV medicines. The study lasts 6 months, and you will be required to come in for 9 study visits during those 6 months.

Study Drugs:

  • Raltegravir

Study Status: Closed to enrollment.

Study Staff:

Study Sponsors:

  • AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

  • Cost-free lab work
  • Transportation reimbursement