Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The medicines used to treat HIV can suppress but cannot kill all the virus in the body. A small amount of virus remains at low levels in the part of the blood called the plasma. It is of crucial importance to identify the source of the residual virus in patients receiving antiretroviral therapy. The purpose of this study is to investigate whether the source of low level plasma virus is from latent (old) infection or ongoing (new) infection. MK-0518 is a investigational drug, which means that is not yet FDA approved, that works in a different way to other anti-HIV medicines to help kill the virus. We hypothesize that addition of MK-0518 to a stable anti-HIV regimen will reduce the viral load further in patients with undetectable plasma virus.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Cancer Institute (NCI)
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

• HIV-1 infection documented by positive HIV-1 ELISA and positive

• Male or female at least 18 years of age, and able to provide written, informed consent

• Current antiretroviral therapy with Department of Health and Human Services (DHHS)-recommended regimen: NRTIs + PI, NRTIs + NNRTI + PI, or NRTIs + NNRTI

• Screening CD4 > 200 cells/ µl and CD4%> 14%; does not require prophylaxis for opportunistic infections

• Receiving a stable antiretroviral regimen for 4 months prior to screening

• HIV-1 RNA level below the limit of detection by commercial HIV-1 RNA determination assays for at least 12 months prior to screening.

• HIV RNA ≥ 0.6 copy RNA/ml plasma by SCA(single copy assay)

• Hgb ≥ 9.0 mg/dl, absolute neutrophil count > 1000/mm3, platelet count > 100,000/mm3

• Alkaline phosphatase, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) < 2.0 x upper limit of normal

• Willing to take MK-0518 for 28 days in addition to ongoing antiretroviral therapy

• Be considered clinically stable, in the opinion of the investigator, at the time of entry into the study; i.e., clinical status and all chronic medications should be unchanged for at least two weeks prior to entry.

Exclusion Criteria:

• Prior participation in an MK-0518 or other integrase inhibitor trial

• Requires prohibited medications noted in the protocol

• Requires cytotoxic agents including hydroxyurea or vaccinations during the study period

• Received immunosuppressive therapy including steroids within one month prior to treatment in this study

• Used any investigational agents within a month prior to treatment in this study

• Documented resistance to any drug in each of the 4 classes of licensed antiretroviral agents by genotype or phenotype

• Any febrile illness (T>38oC) in the 3 weeks prior to enrollment

• Any vaccination in the 6 weeks prior to enrollment

• Diagnosis of acute hepatitis due to any cause

• Positive Hepatitis B surface antigen

• Severe renal insufficiency defined as a calculated creatinine clearance at time of screening as < 30 ml/min, based on the Cockcroft-Gault equation.

• Condition (including but not limited to alcohol or other substance use) which in the opinion of the investigator would interfere with patient compliance or safety