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
Raltegravir 400mg BID Abacavir/Lamivudine 1 tablet QDOther Names:
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|