HIV Infections Clinical Trial
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
Verified date | July 2005 |
Source | Pharmasset |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Fundacion Huesped Clinical Research | Buenos Aires | |
Mexico | Instituto Nacional de Nutricion | Mexico City | |
Panama | Medical Research Center Consultorio Royal Center | Republico de Panama | |
United States | Jacobi Medical Center | Bronx | New York |
United States | Northwestern University | Chicago | Illinois |
United States | Burnside Clinic | Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Pharmasset |
United States, Argentina, Mexico, Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in virological response of HIV (log10 HIV-RNA levels) at the end of week 2 | |||
Primary | Change from baseline in CD4+ count at the end of week 2 | |||
Primary | Adverse events | |||
Secondary | Proportion of subjects in each treatment arm with viral load reduction = 0.5 log10 from baseline | |||
Secondary | Proportion of subjects in each treatment arm with viral load below 50 copies/mL |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |