NCT00300573

Brief Summary

The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Apr 2006

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

First QC Date

March 7, 2006

Last Update Submit

August 22, 2018

Conditions

HIV InfectionsHuman Immunodeficiency Virus

Keywords

dexelvucitabineDFCTreatment ExperiencedHIV-1

Outcome Measures

Primary Outcomes (2)

  • Percent of subjects with >= 1.0 log10 decrease in viral load from Baseline to Week 24 based on non-completer equals failure (NC=F)

    Week 48 compared to baseline

  • Percent of subjects at 48 weeks with sustained suppression of viral load >= 1.0 log10 below baseline as determined by time-to-loss of virological response (TLOVR)

    Week 48 compared to baseline

Secondary Outcomes (8)

  • Median change in viral load from Baseline to Week 24 and to Week 48

    Week 24 or Week 48 compared to baseline

  • Proportion of subjects in each treatment arm with viral load reduction greater than the over all study median viral load reduction

    Week 24 and Week 48

  • Proportion of subjects with a viral load measurement <400 copies/mL at Week 24 and Week 48

    Week 24 and Week 48 compared to baseline

  • Proportion of subjects with a viral load measurement <50 copies/mL at Week 24 and Week 48

    Week 24 and Week 48 compared to Baseline

  • Median change in subset of T lymphocytes (CD4+) cell count from Baseline to Week 24 and Week 48

    Week 24 and Week 48 compared to baseline

  • +3 more secondary outcomes

Study Arms (2)

Dexelvucitabine (DFC)

EXPERIMENTAL

200 mg once daily

Drug: Dexelvucitabine

lamivudine (3TC)

ACTIVE COMPARATOR

300 mg once daily

Drug: Dexelvucitabine

Interventions

DexelvucitabineDRUG

nucleoside inhibitor of HIV Reverse Transcriptase

Dexelvucitabine (DFC)lamivudine (3TC)

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 in # 1-4 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
  • IUD
  • 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.
  • 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.
  • Demonstrate evidence of failure of at least 3 drug classes, defined as #s 1-3 below:
  • 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.
  • Presence of one or more NNRTI-resistance conferring mutations, including mutations at RT amino acids 100I, 101E or 101P, 103N, 106A or 106M, 188L, and/or 190A or 190S or 190E at Screening or documented to be present on a prior genotype OR documented evidence of prior NNRTI use of at least 2 months duration with viral load ≥1000 copies/mL after at least 2 months of treatment.
  • Prior ritonavir-boosted PI use AND presence of one or more PI-resistance-conferring mutations, including mutations at protease amino acids 33F, 46I or 46L, 50V, 82A or 82F or 82T or 82S, 84V, and/or 90M.
  • Demonstrate a Screening plasma HIV RNA concentration of ³1000 copies/mL (Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative assay) and, in the expert judgment of the investigator, be failing the current regimen.
  • Be able and willing to provide written informed consent.
  • +1 more criteria

You may not qualify if:

  • 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.
  • Subjects who are, in the opinion of the investigator, unable to comply with the dosing schedule and protocol evaluations.
  • Pregnant women or women who are breastfeeding
  • 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.
  • Subjects treated with dexelvucitabine (formerly known as Reverset) in a prior investigational drug protocol.
  • Subjects with a history of acute or chronic pancreatitis.
  • Subjects with acute hepatitis B and/or C infection.
  • Subjects with unstable chronic hepatitis.
  • Subjects with chronic renal failure requiring dialysis.
  • 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.
  • Subjects with the following laboratory parameters within 35 days prior to first dose of study medication:
  • Hemoglobin \<9.0 g/dL (males) or \<8.0 g/dL (females)
  • Absolute neutrophil count (ANC) \<750/mm3
  • Platelet count \<75 000/mm3
  • Aspartate aminotransaminase (AST \[SGOT\]) or alanine aminotransaminase (ALT \[SGPT\]) \>5 X upper limit of normal (ULN)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Long Beach, California, 90813, United States

Location

Unknown Facility

Brandon, Florida, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Plantation, Florida, 33317, United States

Location

Unknown Facility

Atlanta, Georgia, 30309, United States

Location

Unknown Facility

Chicago, Illinois, 60657, United States

Location

Unknown Facility

New York, New York, 10018, United States

Location

Unknown Facility

Portland, Oregon, 97209, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

dexelvucitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

April 1, 2006

Study Completion

April 1, 2006

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

US(10)PR(1)