HIV InfectionsPhase 2NCT00121979
Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects
A Phase 2 study testing Racivir, a non-nucleoside reverse transcriptase inhibitor in people with HIV Infections, run by Pharmasset at 6 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Racivir, a non-nucleoside reverse transcriptase inhibitor
- How many people
- 60 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Sep 2004to Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Burnside Clinic
Columbia, South Carolina, 29206
Jacobi Medical Center
The Bronx, New York, 10461
Panama1 site
Medical Research Center Consultorio Royal Center
Republico de Panama
About this study
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
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.
Read the detailed description
The study is divided into four periods: a 'Screening' period which can last up to 30 days in duration, a 'Blinded Treatment' period which can last up to 4 weeks in duration, a 'Follow-up' period which is 28 days in duration, and an 'Open-label Treatment' period that some subjects will be given the option to participate in and which can last up to 20 weeks.
If eligible subjects decide to participate in this research study, they will be randomized, which is like picking chances from a hat, to get RCV (Racivir®) alone, 3TC (lamivudine, Epivir®) alone, or RCV and 3TC (lamivudine, Epivir®) in combination. This is a "double-blind study". This means that neither the subject nor the study doctor and study staff will know if subjects are receiving RCV (Racivir®), 3TC (lamivudine, Epivir®), or RCV (Racivir®) and 3TC (lamivudine, Epivir®). This needs to be done to make sure the researchers obtain the information needed to see if RCV (Racivir®) is safe and as effective as 3TC (lamivudine, Epivir®). In case of an emergency, the study doctor will be able to find out immediately what study drug subjects were receiving. With this exception, by signing the consent form subjects agree that they will not be able to find out what medications they are taking, because this is a "double-blind" study, it is necessary to use placebo tablets. A placebo is a tablet that does not contain any active drug, but is made to look just like the study drug.
Subjects will be given three bottles of study medication. They will be asked to take one tablet from each bottle once a day by mouth, in addition to their current HAART drugs, not including 3TC. The 3TC in their current HAART regimen must be discontinued prior to beginning the study medication. It is important that subjects follow all directions when taking the study drugs.
After completing the first 14 days of the blinded treatment period, subjects will be given the option to continue on their current randomized therapy, including their current study medication, for an additional 1-2 weeks. On Day 15, a blood sample will be collected to determine the amount of HIV virus in the blood. Once the results from that blood sample are available, subjects will be told the amount of how much HIV virus changed in the blood during the first 14 days of treatment. Subjects will also be told if they were receiving RCV (Racivir®) alone, 3TC (lamivudine, Epivir®) alone, or a combination of RCV (Racivir®) and 3TC (lamivudine, Epivir®).
If subjects were receiving RCV (Racivir®), to continue in the open-label treatment period, the amount of virus in the blood must drop by at least 2/3 during the first 14 days of the blinded treatment period. For example, if subjects enter the study with 10,000 copies of the HIV virus per milliliter (ml) of blood, then to continue in the open-label period, the virus level must drop to 3,162 copies or less, per ml of blood. Open-label means that participating subjects and the study doctor or study staff will know what treatment subjects were receiving.
If the virus drops by at least 2/3, subjects will be given the option to enter an open-label treatment period. During the open-label period, subjects will receive 600 mg RCV (Racivir®) once daily along with their regular HAART medications. Before entering the open-label period, the study doctor may decide to change the subject's other ARV medications. Participating subjects will be financially responsible for all medications, other than RCV (Racivir®), that the study doctor may prescribe.
Once treatment is "unblinded", subjects may learn that they were not receiving any RCV (Racivir®) during the blinded treatment period. Subjects may voluntarily decide to add 600 mg RCV (Racivir®) once daily to the other HAART medications. The study doctor may decide to change the subject's HAART medications at this time. After 2 weeks of RCV (Racivir®) based treatment, subjects will be asked to return to the study doctor's office to have blood drawn to determine the amount of HIV virus in the blood. Subjects may continue on RCV (Racivir®) for up to an additional 2 weeks until the results from the blood test are available. If the viral load does not decline by at least 2/3, subjects will be withdrawn from the open-label portion of the study. Subjects will be asked to return to the study doctor's office for a final follow-up visit approximately 28 days after the last dose of RCV (Racivir®).
The open-label treatment period will last no longer than 20 weeks. During this study, subjects can receive up to 24 weeks of RCV (Racivir®) therapy. After subjects receive the last dose of study medication, they will enter the follow-up period for 28 days.
If a participating subject or the study doctor decides to withdraw from the study early, subjects will need to return to the study doctor's office to have a follow-up visit approximately 28 days after the last dose of RCV (Racivir®).
- Conditions
- HIV Infections
- Being tested
- Racivir, a non-nucleoside reverse transcriptase inhibitor
- Keywords
- HIV, treatment-experienced, lamivudine, 3TC
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racivir, a non-nucleoside reverse transcriptase inhibitorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startSep 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Pharmasset
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Murphy, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121979
- Sponsor's protocol ID
- CI-PSI-RCV-04-201
- Status last verified
- Jul 2005
- First submitted
- 18 Jul 2005
- Last updated
- 3 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00121979
- Acronym / sponsor ID
- CI-PSI-RCV-04-201
- Conditions
- HIV Infections
- Keywords
- HIV, treatment-experienced, lamivudine, 3TC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- PharmassetIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Mar 2006
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is divided into four periods: a 'Screening' period which can last up to 30 days in duration, a 'Blinded Treatment' period which can last up to 4 weeks in duration, a 'Follow-up' period which is 28 days in duration, and an 'Open-label Treatment' period that some subjects will be given the option to participate in and which can last up to 20 weeks.
If eligible subjects decide to participate in this research study, they will be randomized, which is like picking chances from a hat, to get RCV (Racivir®) alone, 3TC (lamivudine, Epivir®) alone, or RCV and 3TC (lamivudine, Epivir®) in combination. This is a "double-blind study". This means that neither the subject nor the study doctor and study staff will know if subjects are receiving RCV (Racivir®), 3TC (lamivudine, Epivir®), or RCV (Racivir®) and 3TC (lamivudine, Epivir®). This needs to be done to make sure the researchers obtain the information needed to see if RCV (Racivir®) is safe and as effective as 3TC (lamivudine, Epivir®). In case of an emergency, the study doctor will be able to find out immediately what study drug subjects were receiving. With this exception, by signing the consent form subjects agree that they will not be able to find out what medications they are taking, because this is a "double-blind" study, it is necessary to use placebo tablets. A placebo is a tablet that does not contain any active drug, but is made to look just like the study drug.
Subjects will be given three bottles of study medication. They will be asked to take one tablet from each bottle once a day by mouth, in addition to their current HAART drugs, not including 3TC. The 3TC in their current HAART regimen must be discontinued prior to beginning the study medication. It is important that subjects follow all directions when taking the study drugs.
After completing the first 14 days of the blinded treatment period, subjects will be given the option to continue on their current randomized therapy, including their current study medication, for an additional 1-2 weeks. On Day 15, a blood sample will be collected to determine the amount of HIV virus in the blood. Once the results from that blood sample are available, subjects will be told the amount of how much HIV virus changed in the blood during the first 14 days of treatment. Subjects will also be told if they were receiving RCV (Racivir®) alone, 3TC (lamivudine, Epivir®) alone, or a combination of RCV (Racivir®) and 3TC (lamivudine, Epivir®).
If subjects were receiving RCV (Racivir®), to continue in the open-label treatment period, the amount of virus in the blood must drop by at least 2/3 during the first 14 days of the blinded treatment period. For example, if subjects enter the study with 10,000 copies of the HIV virus per milliliter (ml) of blood, then to continue in the open-label period, the virus level must drop to 3,162 copies or less, per ml of blood. Open-label means that participating subjects and the study doctor or study staff will know what treatment subjects were receiving.
If the virus drops by at least 2/3, subjects will be given the option to enter an open-label treatment period. During the open-label period, subjects will receive 600 mg RCV (Racivir®) once daily along with their regular HAART medications. Before entering the open-label period, the study doctor may decide to change the subject's other ARV medications. Participating subjects will be financially responsible for all medications, other than RCV (Racivir®), that the study doctor may prescribe.
Once treatment is "unblinded", subjects may learn that they were not receiving any RCV (Racivir®) during the blinded treatment period. Subjects may voluntarily decide to add 600 mg RCV (Racivir®) once daily to the other HAART medications. The study doctor may decide to change the subject's HAART medications at this time. After 2 weeks of RCV (Racivir®) based treatment, subjects will be asked to return to the study doctor's office to have blood drawn to determine the amount of HIV virus in the blood. Subjects may continue on RCV (Racivir®) for up to an additional 2 weeks until the results from the blood test are available. If the viral load does not decline by at least 2/3, subjects will be withdrawn from the open-label portion of the study. Subjects will be asked to return to the study doctor's office for a final follow-up visit approximately 28 days after the last dose of RCV (Racivir®).
The open-label treatment period will last no longer than 20 weeks. During this study, subjects can receive up to 24 weeks of RCV (Racivir®) therapy. After subjects receive the last dose of study medication, they will enter the follow-up period for 28 days.
If a participating subject or the study doctor decides to withdraw from the study early, subjects will need to return to the study doctor's office to have a follow-up visit approximately 28 days after the last dose of RCV (Racivir®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Racivir, a non-nucleoside reverse transcriptase inhibitor | Drug | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Murphy, MD study director
Northwestern University
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Racivir, a non-nucleoside reverse transcriptase inhibitor in people with HIV Infections, run by Pharmasset at 6 sites in 4 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Argentina, Mexico, Panama. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in virological response of HIV (log10 HIV-RNA levels) at the end of week 2. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2007.