HIV InfectionsNCT00388492
BLADE: Comparison of Once Daily Lopinavir/Ritonavir to Lopinavir/Ritonavir BID Dosing in HIV-Infected Subjects
An observational study of HIV Infections, run by Bellos, Nicholaos C., M.D. at 1 site in United States.
Trial summary
The goal of this study is to evaluate the proportion of subjects both antiretroviral experienced and virologically suppressed on lopinavir/ritonavir (LPV/r)400/100mg twice daily who maintain viral suppression after switching to lopinavir/ritonavir (LPV/r)800/200mg once daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Documentation HIV infection
- Male or Female
- 18 years of age
- Previously failed an NNRTI and/or 1 previous PI containing regimen
- Currently virologically controlled (VL<50 copies/mL) on a LPV/r containing regimen ≥ 3 months
- Any CD4+ cell count
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- Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
- Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix B) within 30 days of screening
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
- A female is eligible to enter and participate in this study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal) or
- Child-bearing potential, has a negative serum pregnancy test at screen, and agrees to one of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for at least 2 weeks after completion or premature discontinuation of the study to account for elimination of the investigational drug. Should a patient decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the birth control methods below:
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
- Any intrauterine device(IUD) with published data showing that the expected failure rate is <1% per year (not all IUD's meet this criterion)
- Sterilization (female patient or male partner of female patient)
- Any other methods with published data showing that the lowest expected failure rate for that method is <1% per year NOTE: Data are insufficient to exclude a clinically important interaction of LPV/r with drugs, such as hormonal contraceptives, that are highly metabolized by the cytochrome P450 enzyme system. As a result, hormonal contraception is not considered adequate.
Who cannot join
- Pregnancy or breastfeeding
- Hemodialysis or peritoneal dialysis
- Patients unable to provide written informed consent
- Use of concurrent medications known to affect lopinavir and/or ritonavir concentrations (as listed in the attached Kaletra package insert)
- Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) that, in the opinion of the investigator, would prelude the patient from participating in the study (See Appendix B)
- History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule and assessments.
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- Patient is either pregnant at the time of screening evaluation or breast-feeding
- Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen
- Patient suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient
- Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication
- HBV coinfection
- Patient has any of the following laboratory results within 30 days prior to the first dose of study medication:
- Hemoglobin concentration <8.0g/dl
- Absolute neutrophil count <750cells/mm3
- Platelet count <50,000cells/mm3
- Aminotransferase (AST, ALT) >3 times ULN
- Serum creatinine >1.5 times the Upper Limits of Normal (ULN)
- Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period
- Patient requires treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, or interferon's within 4 weeks prior to study entry, or patients who have received an HIV immunotherapeutic vaccine within 3 months prior to entry. Asthmatic patients using inhaled corticosteroids are eligible for enrollment.
- Patient receiving methadone therapy
- Patients requiring foscarnet therapy or therapy with other agents with documented activity against HIV-1 invitro
- Patient prescribed/taking astemizole, terfenadine, cisapride, midazolam, triazolam, flecainide, pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or ergot derivatives (see section 5.5 Concomitant Medications and Non-Drug Therapies and Appendix C
- Patient has a history of allergy to any of the study drugs or any excipients therein.
- In addition, patients non-compliant with study medication during 2-4 week study periods despite adherence counseling will not be retained in the study due to increased risk for selective pressure and potential development of protease resistance.
- Patient requires inhaled or intranasal fluticasone
Trial locations and contacts
1 site in 1 country.
United States1 site
Nicholaos C. Bellos, MD
Dallas, Texas, 75204
Keri Neuling, 214-828-4702 ext. 122, kneuling@drbelllos.com
Denise Ramos, 214-828-4702 ext. 102, dramos@drbellos.com
About this study
Official title: BLADE: "A Comparison of Once Daily LPV/r to LPV/r BID in HIV-Infected Virologically Controlled Antiretroviral Experienced Subjects"
The goal of this study is to evaluate the proportion of subjects both antiretroviral experienced and virologically suppressed on lopinavir/ritonavir (LPV/r)400/100mg twice daily who maintain viral suppression after switching to lopinavir/ritonavir (LPV/r)800/200mg once daily.
The hypothesis for this study is that the majority of subjects will remain virologically suppressed with once daily dosing versus twice daily dosing and therefore quality of life will be improved with the once daily dosing of lopinavir/ritonavir (LPV/r)800/200mg.
- Conditions
- HIV Infections
- Keywords
- HIV Infected
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Bellos, Nicholaos C., M.D.
- Investigators
- Nicholaos C. Bellos, MD, Principal investigator, Nicholaos C. Bellos, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388492
- Sponsor's protocol ID
- 70-1002-075
- Status last verified
- Oct 2006
- First submitted
- 12 Oct 2006
- Last updated
- 11 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLADE: "A Comparison of Once Daily LPV/r to LPV/r BID in HIV-Infected Virologically Controlled Antiretroviral Experienced Subjects"
- ClinicalTrials.gov ID
- NCT00388492
- Acronym / sponsor ID
- 70-1002-075
- Conditions
- HIV Infections
- Keywords
- HIV Infected
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- Bellos, Nicholaos C., M.D.
- First posted
- 16 Oct 2006 (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.
The goal of this study is to evaluate the proportion of subjects both antiretroviral experienced and virologically suppressed on lopinavir/ritonavir (LPV/r)400/100mg twice daily who maintain viral suppression after switching to lopinavir/ritonavir (LPV/r)800/200mg once daily.
The hypothesis for this study is that the majority of subjects will remain virologically suppressed with once daily dosing versus twice daily dosing and therefore quality of life will be improved with the once daily dosing of lopinavir/ritonavir (LPV/r)800/200mg.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Documentation HIV infection
- Male or Female
- 18 years of age
- Previously failed an NNRTI and/or 1 previous PI containing regimen
- Currently virologically controlled (VL<50 copies/mL) on a LPV/r containing regimen ≥ 3 months
Key exclusion criteria (25 listed)
- Pregnancy or breastfeeding
- Hemodialysis or peritoneal dialysis
- Patients unable to provide written informed consent
- Use of concurrent medications known to affect lopinavir and/or ritonavir concentrations (as listed in the attached Kaletra package insert)
- Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) that, in the opinion of the investigator, would prelude the patient from participating in the study (See Appendix B)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 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.
Nicholaos C. Bellos, MD principal investigator
Nicholaos C. Bellos, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Bellos, Nicholaos C., M.D. at 1 site in United States.
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 17 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 11 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keri Neuling (214-828-4702 ext. 122, kneuling@drbellos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Jan 2007.