Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1 (UW PIC 330)

University of Washington

Status and phase: Terminated; Phase 4

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Raltegravir; Drug: 3-drug anti-HIV therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00781287

34908-D

Details and patient eligibility

About

This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.

Full description

The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute or Early HIV-1 infection
• HIV-1 RNA > or equal to 500 copies/mL
• Acceptable safety lab results (specified in protocol)
• Negative pregnancy test for females
• Willingness to use contraception (for females of reproductive potential

Exclusion criteria

• Prior receipt of investigational HIV-1 vaccine
• Use of immunomodulators other than systemic steroids within 30 days before entry
• Serious medical or psychiatric illness that would interfere with study participation
• Active drug or alcohol use that would interfere with study participation
• Allergy/hypersensitivity to raltegravir
• Pre- or Post-exposure prophylaxis for the exposure that led to HIV-1 acquisition
• Pregnancy or breastfeeding
• History of malignancy (other than localized squamous cell or basal cell cancer of the skin)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Raltegravir + 3-drug anti-HIV therapy

Experimental group

Treatment:

Drug: 3-drug anti-HIV therapy

Drug: Raltegravir

3-drug anti-HIV therapy

Active Comparator group

Treatment:

Drug: 3-drug anti-HIV therapy