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| Sponsor: | Pharmasset |
|---|---|
| Information provided by: | Pharmasset |
| ClinicalTrials.gov Identifier: | NCT00121979 |
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 II |
| 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 |
| 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 |
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.
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Robert Murphy, MD | Northwestern University |
More Information
| 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 |
|
HIV treatment-experienced lamivudine 3TC |
|
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 |