Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects

This study has been completed.
Sponsor:
Information provided by:
Pharmasset
ClinicalTrials.gov Identifier:
NCT00121979
First received: July 18, 2005
Last updated: July 2, 2007
Last verified: July 2005
  Purpose

Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United States Food and Drug Administration (FDA), but it can be used in research studies like this one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine, Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®).

The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when used together with other HIV drugs in people who have previously been treated with 3TC (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at approximately 11 study sites in the US and Latin America.


Condition Intervention Phase
HIV Infections
Drug: Racivir, a non-nucleoside reverse transcriptase inhibitor
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Exploring the Safety, Tolerability, and Antiviral Effect of Substituting 600 mg Racivir for 3TC in HIV-Infected Subjects Who Have the M184V Mutation and Are Currently Failing on a HAART Regimen Containing Lamivudine

Resource links provided by NLM:


Further study details as provided by Pharmasset:

Primary Outcome Measures:
  • Change from baseline in virological response of HIV (log10 HIV-RNA levels) at the end of week 2
  • Change from baseline in CD4+ count at the end of week 2
  • Adverse events

Secondary Outcome Measures:
  • Proportion of subjects in each treatment arm with viral load reduction ≥ 0.5 log10 from baseline
  • Proportion of subjects in each treatment arm with viral load below 50 copies/mL

Estimated Enrollment: 60
Study Start Date: September 2004
Estimated Study Completion Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females who are between 18 years (or the legal age of consent, whichever is older) and 65 years of age. Females may be enrolled following a negative pregnancy test if:

    a) they are documented to be surgically sterile or post-menopausal [amenorrhea >1 year and FSH >30mU/mL]; --OR-- b) they are using a hormonal birth control method (oral contraceptives, contraceptive implants); --OR-- c) they are using a barrier method of contraception (male or female condoms, diaphragm, cervical cap) with a spermicide.

  • Subjects with a positive history of HIV-infection, documented by a licensed HIV antibody ELISA assay and confirmed either by Western blot, positive HIV blood culture, positive HIV serum antigen or plasma viremia.
  • Subjects currently on an accepted, stable HAART regimen that includes lamivudine for at least 60 days prior to screening.
  • Subjects who, in the opinion of the investigator, are failing their current HAART regimen.
  • Subjects who have an HIV-RNA copy number of ≥ 2000 copies/mL as determined by FDA-approved, Roche PCR assay (Amplicor HIV-1 Monitor® Test, v1.5 – Quantitative).
  • Subjects who have a CD4-lymphocyte count ≥ 50 cells/mm3.
  • Subjects who have the M184V HIV mutation, as determined by the FDA-approved Bayer assay, TRUGENE® HIV-1 Genotyping Kit and the OpenGene® DNA Sequencing System.
  • Subjects who are able and willing to provide written, informed consent.
  • Subjects who are able and willing to comply with the requirements of this study.

Exclusion Criteria:

  • Subjects who have a current or recent (< 30 days) opportunistic infection characteristic of AIDS (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version).
  • Subjects currently on a (-)-FTC regimen.
  • Subjects with Q151M mutation.
  • Subjects with T69S insertions.
  • Female subjects who are pregnant or breastfeeding.
  • Subjects enrolled in other investigational drug protocols or subjects who have received other investigational agents within 30 days prior to the first dose of study medication. For investigational drugs with an elimination half-life greater than 15 days, this will be extended to 60 days.
  • Subjects with malabsorption syndromes possibly affecting drug absorption (e.g. Crohn’s disease, chronic pancreatitis, etc).
  • Subjects with acute hepatitis B and/or C, except for subjects who, at the discretion of the investigator, have a chronic, but stable hepatitis infection.
  • Subjects with the following laboratory parameters within 30 days prior to the first dose of study medication: *Hemoglobin <10.0 g/dL; *Absolute neutrophil count (ANC) <1000/mm3; *Platelet count <100,000/mm3; *AST or ALT >5 times the upper limit of normal, without the presence of an underlying illness, other than HIV or acute hepatitis, judged by the investigator to likely cause such chronic enzyme abnormalities; *Pancreatic amylase >1.5 times the upper limit of normal.
  • Subjects who have received an HIV vaccination within 6 months prior to the first dose of study medication.
  • Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents within 30 days prior to the first dose of study medication.
  • Subjects who, in the opinion of the investigator, are unable to comply with the dosing schedule and protocol evaluations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121979

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
Argentina
Fundacion Huesped Clinical Research
Buenos Aires, Argentina, C1202ABB
Mexico
Instituto Nacional de Nutricion
Mexico City, Mexico, 14000
Panama
Medical Research Center Consultorio Royal Center
Republico de Panama, Panama
Sponsors and Collaborators
Pharmasset
Investigators
Study Director: Robert Murphy, MD Northwestern University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00121979     History of Changes
Other Study ID Numbers: CI-PSI-RCV-04-201
Study First Received: July 18, 2005
Last Updated: July 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmasset:
HIV
treatment-experienced
lamivudine
3TC

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Racivir
Lamivudine
Reverse Transcriptase Inhibitors
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 28, 2014