Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects
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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 |
- 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
- 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 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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 |
Study Director: | Robert Murphy, MD | Northwestern University |
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 2',3'-dideoxy-5-fluoro-3'-thiacytidine |
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 October 16, 2012