HIV InfectionsPhase 4KALYINTENCT01045369
A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
A Phase 4 study testing Kaletra and Intelence Tablets in people with HIV Infections, run by Therapeutic Concepts at 1 site in United States.
Trial summary
The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental. 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?
- Kaletra and Intelence Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 RNA ≥ 5000 copies/mL by Roche Amplicor 1.5v Primer
- More than 18 years of age
- Provide written informed consent and willingness to participate in and comply
- Less than 7 days of prior ART with any licensed or investigational compound
- Does not currently have or has not been treated for an active opportunistic infection (OI) within 30 days of screening
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
- A female who is a non-childbearing potentiator or if in 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 from 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 like double barrier method, intrauterine device, sterilization and any other methods.
- 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
- Patient with active AIDS-defining opportunistic infection in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
- Patient has a weighted genotypic score for etravirine ≥3 . (See Appendix D)
- Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V).
- History of active substance abuse.
- Pregnant at 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.
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- 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
- Malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
- Undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
- HBV co-infection
- Laboratory results within 30 days prior to the first dose of study medication:
- Hemoglobin concentration < 8.0 g/dL
- Absolute neutrophil count < 750 cells/mm3
- Platelet count <50,000 cells/ mm3
- Aminotransferase (AST, ALT) >3 times ULN
- Serum creatinine >1.5 times the Upper Limits of Normal (ULN)
- Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.
- 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.
- Methadone therapy
- Foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
- Taking astemizole, terfenadine, cisapride, oral midazolam, triazolam, flecainide, pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or ergot derivatives.
- Allergy to any of the study drugs or any excipients therein.
- Patient requires inhaled or intranasal fluticasone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.
- Conditions
- HIV Infections
- Being tested
- Kaletra and Intelence Tablets
- Keywords
- HIV, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaletra and Intelence TabletsDrug
Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Kaletra And Intelence | Experimental | This is a Phase IV, 48-week, open-label, pilot study in 30 ARV-naïve patients examining the safety, viral response, and tolerability of Kaletra® and Intelence™ tablets. Receives: Drug: Kaletra and Intelence Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48
Measured: At weeks 24 and 48
Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48
Measured: At weeks 24 and 48
Secondary outcomes (2)
Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit
Measured: At weeks 24 and 48
Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively
Measured: At weeks 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionJun 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therapeutic Concepts
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Tibotec, Inc, BluKyne
- Responsible party
- Principal investigator, Joseph Gathe Jr. M.D., Therapeutic Concepts
- Investigators
- Joseph C. Gathe, Jr., MD, Principal investigator, Therapeutic Concepts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045369
- Sponsor's protocol ID
- 101-001
- Acronym
- KALYINTE
- Status last verified
- Jan 2010
- First submitted
- 8 Jan 2010
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
- ClinicalTrials.gov ID
- NCT01045369
- Acronym / sponsor ID
- KALYINTE / 101-001
- Conditions
- HIV Infections
- Keywords
- HIV, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Therapeutic ConceptsUniversity, hospital or other
- Collaborators
- Abbott, Tibotec, Inc, BluKyne
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Jan 2010 (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 purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kaletra And Intelence | Experimental | Drug: Kaletra and Intelence TabletsThis is a Phase IV, 48-week, open-label, pilot study in 30 ARV-naïve patients examining the safety, viral response, and tolerability of Kaletra® and Intelence™ tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV-1 RNA ≥ 5000 copies/mL by Roche Amplicor 1.5v Primer
- More than 18 years of age
- Provide written informed consent and willingness to participate in and comply
- Less than 7 days of prior ART with any licensed or investigational compound
- Does not currently have or has not been treated for an active opportunistic infection (OI) within 30 days of screening
Key exclusion criteria (23 listed)
- Patient with active AIDS-defining opportunistic infection in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
- Patient has a weighted genotypic score for etravirine ≥3 . (See Appendix D)
- Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V).
- History of active substance abuse.
- Pregnant at time of screening evaluation or breast-feeding.
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 |
|---|---|---|
| Kaletra and Intelence TabletsKaletra 400 mg twice a day and Intelence Tablets 200mg twice a day. | Drug | Kaletra And Intelence |
Primary outcome
Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48
Time frame: At weeks 24 and 48
Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48
Time frame: At weeks 24 and 48
2 secondary outcomes
Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit
Time frame: At weeks 24 and 48
Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively
Time frame: At weeks 24 and 48
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 1 May 2017.
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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.
Joseph C. Gathe, Jr., MD principal investigator
Therapeutic Concepts
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 Kaletra and Intelence Tablets in people with HIV Infections, run by Therapeutic Concepts 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 8 inclusion and 23 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 1 May 2017. 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?
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?
Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48 (time frame: At weeks 24 and 48). The study lists 2 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 1 May 2017.