Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects — SHIELD  

HIV Infections Clinical Trial

Official title: A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects

Status Active, not recruiting

Clinical Trial Summary

To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.

Clinical Trial Description

• This is a single-arm, multicenter, open-label, pilot study to evaluate the efficacy, safety, and tolerability of RTG BID and ABC/3TC QD. A total of 30 subjects will be enrolled at 3 U.S. sites.

• The study includes a 30-day screening period, a treatment period (baseline through week 48), and a follow-up visit, 2 to 4 weeks after the last study visit, as needed to resolve any ongoing AEs or to confirm virologic status.

Virologic failure (VF) is defined as having either virologic non-response or virologic rebound. Virologic failure is confirmed by having 2 consecutive plasma HIV-1 RNA levels taken at least 2 weeks apart according to the following definitions:

• virologic rebound is defined as HIV-1 RNA level ≥400 copies/mL after initial response of HIV-1 RNA <400 copies/mL or >1 log10 copies/mL increase above nadir;

• virologic non-response is defined as HIV-1 RNA >400 copies/mL at week 24.

• Subjects will be discontinued from the study if virologic failure is confirmed. When a subject is suspected to have virologic failure, a confirmatory HIV-1 RNA must be performed at an unscheduled visit between 2 weeks and 4 weeks after the initial assessment, and a plasma sample collected for resistance testing.

• Subjects who experience symptoms consistent with a clinically suspected ABC HSR must permanently discontinue ABC/3TC, and will be allowed to substitute study-provided fixed-dose combination ZDV/3TC 150/300 mg (COMBIVIR®) BID for ABC/3TC and remain in the study. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT00740064
• Study type: Interventional
• Source: Denver Infectious Disease Consultants, PLLC
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2008
• Completion date: November 2009