A Randomized, Double-Blind, Phase II Study Comparing the Anti-Retroviral Safety and Efficacy of Dexelvucitabine (DFC) 200 mg Once Daily to Lamivudine (3TC) 300 mg Once Daily in Addition to Optimized Background Therapy in HIV-1 Infected Subjects Who Have Failed and/or Harbor HIV with Resistance Mutations to NRTIs, PIs, and NNRTIs - DECLARE 1

Incyte Corporation0 sites250 target enrollmentFebruary 24, 2006

DrugsEpivir 150 mg film coated tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Incyte Corporation
Enrollment: 250
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 24, 2006

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Incyte Corporation

Eligibility Criteria

Inclusion Criteria

•1\. a) Male (at birth) subjects, between 16 years (or the legal age of consent, whichever is older) and 75 years of age, utilizing adequate contraceptive methods.
•b) Female (at birth) subjects between 16 years (or the legal age of consent, whichever is older) and 75 years of age.
•Women of childbearing potential may be enrolled following a negative serum pregnancy test. If participating in activity that could lead to pregnancy, women shall agree to use TWO forms of contraception as listed below (at least one must be a barrier method) while receiving protocol\-specified medication and for 2 months after stopping the medication.
•Condom (male or female) with or without a spermicidal agent
•Diaphragm or cervical cap with spermicide
•Hormonal\-based contraception
•Women who are not of reproductive potential (documented to be surgically sterile or postmenopausal \[defined as amenorrhea \>1 year and follicle stimulating hormone {FSH} \>30 mU/mL]) are eligible to be enrolled without a serum pregnancy test and will not be required to use contraception.
•2\. Subjects treated with a HAART regimen(s), including a minimum of 3 drugs, for at least 3 months and who have been on a stable HAART regimen for a minimum of 8 weeks prior to the Screening visit. The HAART regimen must also remain stable from the Screening visit until randomization on Day 0 in order for the subject to qualify for enrollment.
•3\. Demonstrate evidence of failure of at least 3 drug classes, defined as follows:
•a) Prior NRTI use and presence of one or more NRTI\-resistance\-conferring mutations, including mutations at RT amino acids 41L, 65R, 67N, 70R, 74V or 74I, 184V or 184I, 210W, 215Y or 215F, and/or 219Q or 219E.

Exclusion Criteria

•1\. Current or recent (\<30 days) opportunistic infection (Category C according to the Centers for Disease Control (CDC) Classification System for HIV\-1 Infection, 1993 Revised Version) that is not being controlled by medication in the judgment of the investigator.
•2\. Subjects who are, in the opinion of the investigator, unable to comply with the dosing schedule and protocol evaluations.
•3\. Pregnant women or women who are breastfeeding.
•4\. Current alcohol or drug use, which in the expert judgment of the investigator, will interfere with the subject’s ability to comply with the protocol requirements.
•5\. Subjects treated with dexelvucitabine (formerly known as Reverset) in a prior investigational drug protocol.
•6\. Subjects with a history of acute or chronic pancreatitis.
•7\. Subjects with acute hepatitis B and/or C infection.
•8\. Subjects with unstable chronic hepatitis.
•9\. Subjects with chronic renal failure requiring dialysis.
•10\. Subjects currently receiving 3TC or FTC as part of a regimen for treatment of stable, chronic HBV infection. Subjects with stable chronic HBV infection who are being treated with entecavir, adefovir, or tenofovir are eligible to enroll.