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A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects
To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.
* 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Spectrum Medical Group
Phoenix, Arizona, United States
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Start Date
May 1, 2008
Primary Completion Date
August 1, 2009
Completion Date
November 1, 2009
Last Updated
January 28, 2009
30
ESTIMATED participants
Raltegravir and Abacavir/Lamivudine
DRUG
Lead Sponsor
Denver Infectious Disease Consultants, PLLC
Collaborators
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330