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

Phase 4

Terminated

• Conditions: Human Immunodeficiency Virus
• Interventions: Drug: 3-drug anti-HIV therapy; Drug: Raltegravir

• Registration Number: NCT00781287
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-28
• Study Start: 2009-02
• Primary Completion: 2012-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raltegravir + 3-drug anti-HIV therapy	3-drug anti-HIV therapy	-
3-drug anti-HIV therapy	3-drug anti-HIV therapy	-
Raltegravir + 3-drug anti-HIV therapy	Raltegravir	-

Primary Outcome Measures

Name	Time	Method
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay	96 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma HIV-1 RNA	Baseline to Week 8
CD4+ T-cells	96 weeks
Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline	From study drug start to 8 weeks after drug discontinuation
Tolerability (Discontinuation of raltegravir)	96 weeks

Trial Locations

Locations (1)

University of Washington Primary Infection Clinic; 🇺🇸 Seattle, Washington, United States