Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects (SHIELD)
|ClinicalTrials.gov Identifier: NCT00740064|
Recruitment Status : Unknown
Verified January 2009 by Denver Infectious Disease Consultants, PLLC.
Recruitment status was: Active, not recruiting
First Posted : August 22, 2008
Last Update Posted : January 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Raltegravir and Abacavir/Lamivudine||Phase 4|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||November 2009|
Drug: Raltegravir and Abacavir/Lamivudine
- To evaluate the efficacy and safety of RTG and ABC/3TC over 48 weeks in ART-naive HIV-infected subjects. [ Time Frame: 48 weeks ]
- To assess the immunologic response, changes in fasting lipids, renal function, and development of resistance of the study regimen [ Time Frame: 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740064
|United States, Arizona|
|Spectrum Medical Group|
|Phoenix, Arizona, United States, 85012|
|United States, Colorado|
|Denver Infectious Disease Consultants, PLLC|
|Denver, Colorado, United States, 80220|
|United States, New Mexico|
|Southwest CARE Center|
|Santa Fe, New Mexico, United States, 87505-4765|
|Principal Investigator:||Benjamin Young, MD, PhD||Denver Infectious Disease Consultants, PLLC|