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

Human Immunodeficiency Virus Clinical Trial

— UW PIC 330  

Official title:

Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00781287
• Other study ID #: 34908-D
• Status: Terminated
• Phase: Phase 4
• First received: October 24, 2008
• Last updated: August 8, 2013
• Start date: February 2009
• Est. completion date: October 2013

Study information

• Verified date: August 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• 3-drug anti-HIV therapy
3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs)
• Raltegravir
400 mg BID PO

Locations

Country	Name	City	State
United States	University of Washington Primary Infection Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay		96 weeks
Secondary	CD4+ T-cells		96 weeks
Secondary	Plasma HIV-1 RNA		96 weeks
Secondary	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
Secondary	Plasma HIV-1 RNA		Baseline to Week 8
Secondary	Tolerability (Discontinuation of raltegravir)		96 weeks

External Links

•   University of Washington Primary Infection Clinic web site