HIV InfectionsPhase 4NCT00679926
Kaletra and Viread in Antiretroviral Naïve Patients
A Phase 4 study testing Once daily in people with HIV Infections, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients >18 years of age with documented HIV-1 infection
- Naïve to antiretroviral therapy
- Able and willing to provide written informed consent
- No CD4 restriction
- HIV-1 RNA levels >5000 c/mL
- Female patients must meet these additional criteria
Show all 9Show fewer
- Non-childbearing potential
- Negative serum pregnancy test at screen
- Willingness to abstain from sexual intercourse or use double barrier contraception
Who cannot join
- Presence of any of the following:
- Aminotransferases >3xULN
- Hemoglobin concentration <8.0g/dl
- Absolute neutrophil count <800 cells/cubic mm
- Platelet count <50,000 cells/cubic mm
- Acute illness, or an acute illness ≤7 days
Show all 15Show fewer
- Presence of Opportunistic Infection, or an OI within 30 days of screening
- Acute or chronic active Hepatitis B
- Hepatitis C
- Creatinine Clearance <50 mL/min
- Pregnant or breast-feeding women
- Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
- Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
- Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
- Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
OSU Internal Medicine Specialty Clinic
Tulsa, Oklahoma, 74127
About this study
Official title: A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
Read the detailed description
This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.
Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.
- Conditions
- HIV Infections
- Being tested
- Once daily
- Keywords
- HIV, AIDS, HIV/AIDS, Treatment Naive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once dailyDrug
Also called Kaletra, Viread
Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
| Study group | Role | What they receive |
|---|---|---|
| Once daily | Experimental | Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours. Receives: Drug: Once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients.
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to <50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
Measured: 4, 8, 12, 16, 24, 32, 40, and 48 weeks
Secondary outcomes (11)
Proportion of Patients With <400copies/ml
Proportion of patients with <400copies/ml will be done by determining plasma HIV-1 RNA levels
Measured: 4,8, and 12 weeks
Review Virologic Response to Assess Rate of Viral Decline.
Review virologic response to assess rate of viral decline through CD4 count at baseline and throughout the study.
Measured: weeks 4, 8, 12, 16, and 24
Proportion of Patients With <50 Copies/ml HIV-1 RNA
Proportion of patients with <50 copies/ml HIV-1 RNA through evaluation of patients Plasma HIV-1 RNA levels
Measured: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Change From Baseline CD4 Counts
CD4 count done at baseline and throughout the study.
Measured: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Time to Virologic Failure.
Virologic failure is defined by any of the following: 1) <1 log10 decline in HIV RNA by week 8 of therapy; 2) failure to achieve <50 c/mL by week 24; 3) HIV RNA> 500 c/ML on two consecutive occasions (less than 30 days apart), with no evidence of suppression after adherence counseling. When HIV RNA levels are obtained >500 copies/mL it will be repeated within 2 weeks. If after adherence counseling, HIV RNA demonstrates > 1 log 10 decline but remains >500, the patient will receive a final adherence counseling session and have his/her HIV RNA measure repeated at day 30: if a third consecutive HIV RNA remains 500 c/mL the patient will be removed from study, if <500c/mL the patient will remain on study
Measured: Week 48
Tolerability and Adverse Events.
Adverse events and safety parameters are monitored for ll subjects for the duration of the study. Toxicities and adverse events will be graded using the modified ACTG toxicity ratings scale. Study drugs may be interrupted for safety reasons and/or based on grade of toxicity/adverse event.
Measured: 48 weeks
Change From Baseline Fasting Total Cholesterol and Fasting Triglyceride Levels.
Change from baseline fasting total cholesterol and fasting triglyceride levels will be measured by fasting lipid panels taken at baseline and at various timepoints.
Measured: 48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by the Use of Medication Electronic Monitoring Systems (MEMS) Caps.
The medication event monitoring system (MEMS) is a cap that fits on standard medicine bottles and records the time and date each time the bottle is opened and closed.
Measured: 48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by Use of Pharmacy Refill Records.
Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records is assessed by an examination of pharmacy refill data for patients.
Measured: 48 weeks
Assess Genotypic Changes in Patients With Virologic Failure.
At time of virologic failure genotypes will be performed on baseline and failure isolates; phenotypic testing will be performed on failure isolates to examine LPV susceptibility.
Measured: 48 weeks
Assess Lopinavir Trough Levels in Patients Failing to Obtain Virologic Suppression.
Assess lopinavir trough levels in patients failing to obtain virologic suppression by measuring lopinavir trough level
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Johnny Stephens, Oklahoma State University Center for Health Sciences
- Investigators
- Damon Baker, D.O., Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679926
- Sponsor's protocol ID
- Baker - 001
- Status last verified
- Dec 2020
- First submitted
- 15 May 2008
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.
- ClinicalTrials.gov ID
- NCT00679926
- Acronym / sponsor ID
- Baker - 001
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, HIV/AIDS, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 May 2008 (estimated)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
Detailed description
This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.
Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Once daily | Experimental | Drug: Once dailyPatients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients >18 years of age with documented HIV-1 infection
- Naïve to antiretroviral therapy
- Able and willing to provide written informed consent
- No CD4 restriction
- HIV-1 RNA levels >5000 c/mL
Key exclusion criteria (15 listed)
- Presence of any of the following:
- Pregnant or breast-feeding women
- Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
- Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
- Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
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 |
|---|---|---|
| Once dailyAlso: Kaletra, VireadFour tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily | Drug | Once daily |
Primary outcome
To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients.
Time frame: 4, 8, 12, 16, 24, 32, 40, and 48 weeks
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to <50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
11 secondary outcomes
Proportion of Patients With <400copies/ml
Time frame: 4,8, and 12 weeks
Review Virologic Response to Assess Rate of Viral Decline.
Time frame: weeks 4, 8, 12, 16, and 24
Proportion of Patients With <50 Copies/ml HIV-1 RNA
Time frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Change From Baseline CD4 Counts
Time frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Time to Virologic Failure.
Time frame: Week 48
Tolerability and Adverse Events.
Time frame: 48 weeks
Change From Baseline Fasting Total Cholesterol and Fasting Triglyceride Levels.
Time frame: 48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by the Use of Medication Electronic Monitoring Systems (MEMS) Caps.
Time frame: 48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by Use of Pharmacy Refill Records.
Time frame: 48 weeks
Assess Genotypic Changes in Patients With Virologic Failure.
Time frame: 48 weeks
Assess Lopinavir Trough Levels in Patients Failing to Obtain Virologic Suppression.
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Damon Baker, D.O. principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Once daily in people with HIV Infections, run by Oklahoma State University Center for Health Sciences 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 4 Dec 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients. (time frame: 4, 8, 12, 16, 24, 32, 40, and 48 weeks). 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 4 Dec 2020.