Status:
COMPLETED
Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 impor...
Detailed Description
This is a non-randomized, non-comparative, single center trial of antiretroviral therapy intensification using the investigational integrase inhibitor MK-0518 and an investigational viral load assay t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00618371
Start Date
October 1 2007
End Date
March 1 2009
Last Update
February 1 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213