Raltegravir Intensification in HIV-infected Patients

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Raltegravir; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00631449

H52899-31393-03

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable antiretroviral therapy for at least 12 months
• Screening CD4+ T cell count < 350 cells/mm3
• All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
• Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA or < 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations).
• >90% adherence to therapy within the preceding 30 days, as determined by self-report
• Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion criteria

• Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason
• Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
• **Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period
• Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks
• Concurrent treatment with phenobarbital, phenytoin, or rifampin.
• Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Raltegravir

Active Comparator group

Description:

For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.

Treatment:

Drug: Raltegravir

Placebo

Placebo Comparator group

Description:

For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.

Treatment:

Drug: Placebo