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HIV InfectionsPhase 2DECLARENCT00300573

Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs

A Phase 2 study testing Dexelvucitabine in people with HIV Infections and Human Immunodeficiency Virus, run by Incyte Corporation at 11 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
HIV Infections, Human Immunodeficiency Virus
What is being tested?
Dexelvucitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
11 sitesin 2 countries
Study dates
Apr 2006to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Be able and willing to comply, in the opinion of the investigator, with the requirements of this study.

Who cannot join

  • 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.
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  • 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)
  • Serum lipase >1.5 X ULN
  • Serum creatinine > 3.0 x ULN
  • Subjects who have received an HIV prophylactic or corrective vaccination within 6 months prior to the first dose of study medication.
  • Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents and have not recovered from side effects prior to the first dose of study medication.
  • Subjects with RT mutations Q151M or T69SS on Screening genotype.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States10 sites

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Brandon, Florida

  • Study site

    Chicago, Illinois, 60657

  • Study site

    Dallas, Texas

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Long Beach, California, 90813

  • Study site

    Miami, Florida

  • Study site

    New York, New York, 10018

  • Study site

    Plantation, Florida, 33317

  • Study site

    Portland, Oregon, 97209

Other trials in United States

Puerto Rico1 site

  • Study site

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: 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

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).

Read the detailed description

The study will compare the safety and efficacy of an investigational nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC) 200 mg once daily, to an approved NRTI, lamivudine (3TC) 300 mg once daily in treatment experienced patients with HIV that is 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 based on prior treatment history, and results of HIV genotype and phenotype performed during screening. In addition to the OBR patients will be randomized to receive at at one to one ratio DFC or 3TC in a blinded fashion. The OBR may include any approved HIV treatments except 3TC, FTC, ddI, d4T and ddC. Medications available through expanded access may also be available to selected patients. Treatment in the study will continue for up to 96 weeks with primary endpoints at 24 and 48 weeks of therapy. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch study medication (DFC to 3TC or 3TC to DFC). A total of 250 patients will be enrolled.

Being tested
Dexelvucitabine
Keywords
dexelvucitabine, DFC, Treatment Experienced, HIV-1
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexelvucitabineDrug

    nucleoside inhibitor of HIV Reverse Transcriptase

Study groups in NCT00300573
Study groupRoleWhat they receive
Dexelvucitabine (DFC)Experimental200 mg once daily
Receives: Drug: Dexelvucitabine
lamivudine (3TC)Active comparator300 mg once daily
Receives: Drug: Dexelvucitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 48 compared to baseline

  2. 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)

    Measured: Week 48 compared to baseline

Secondary outcomes (8)

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

    Measured: Week 24 or Week 48 compared to baseline

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

    Measured: Week 24 and Week 48

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

    Measured: Week 24 and Week 48 compared to baseline

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

    Measured: Week 24 and Week 48 compared to Baseline

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

    Measured: Week 24 and Week 48 compared to baseline

  6. Proportion of subjects with a 50% decrease and/or 100 cell/mm3 decrease in CD4+ cell count to Week 24 and to Week 48

    Measured: Week 24 and Week 48 compared to baseline

  7. Proportion of subjects who "crossed-over" to receive treatment with the other blinded study medication

    Measured: Week 16 and visits thereafter

  8. Number of Centers for Disease Control (CDC) Class C adverse events and deaths by treatment arm

    Measured: approximately every 2 to 4 weeks for laboratory testing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2006 (estimated)
  2. Study startApr 2006
  3. Study completionApr 2006

Why it stopped: Development program ended due to inability to pair with other cytidine analogs and higher risk of hyperlipasemia when not used with 3TC/FTC.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00300573
Sponsor's protocol ID
INCB 08721-204
Other IDs
EudraCT #:2006-000096-16
Acronym
DECLARE
Status last verified
Aug 2018
First submitted
7 Mar 2006
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexelvucitabine in people with HIV Infections and Human Immunodeficiency Virus, run by Incyte Corporation at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Development program ended due to inability to pair with other cytidine analogs and higher risk of hyperlipasemia when not used with 3TC/FTC.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of subjects with >= 1.0 log10 decrease in viral load from Baseline to Week 24 based on non-completer equals failure (NC=F) (time frame: Week 48 compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00300573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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