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HIV InfectionsPhase 1/2NCT02229760

Effect of Steady State TPV/r on Intracellular Concentrations of Zidovudine and Carbovir for Patients With HIV

A Phase 1/2 study testing Tipranavir capsules and Ritonavir capsules in people with HIV Infections, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate (CBV-TP) and plasma viral load Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV Infections
What is being tested?
Tipranavir capsules and Ritonavir capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
No sites listed yet
Study dates
Aug 2006to Sep 2007
Phase
Phase 1/2
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed informed consent before study participation
  • Age >18 and <60 years
  • Female patients of child-bearing potential who use a barrier contraceptive method for at least 12 weeks before administration of study medication, during the study and for 28 days after administration of study medication has ended and who have a negative pregnancy test result
  • Ability to swallow capsules without difficulty
  • A Body Mass Index (BMI) between 18 and 29 kg/m2
  • Reasonable probability of completing the study
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  • A medical history, physical examination, and electrocardiogram (ECG) before entering the study
  • Agreement to abstain from alcohol from Day -2 to Day 24
  • Agreement to abstain from ingesting grapefruit, grapefruit juice, Seville oranges or orange marmalade from Day -2 to Day 24
  • Negative urine drug screen for drugs of abuse
  • Documented HIV-1 RNA load (by PCR) at screening of <50 copies/mL for at least 3 months and on a stable ZDV or ABC regimen for at least 6 months. Acceptable documentation included laboratory data, letter, or verbal report from another provider noted in the patient's records
  • All HIV-infected patients must be TPV naïve and must not have received a PI based regimen within 6 months of enrollment

Who cannot join

  • Female patients who had a positive serum pregnancy test during the screening period of Day -14 to Day -7 or who plan to breast-feed at time (Day 0 to 30 after TPV/r administration)
  • Use of any other investigational medicine within 30 days before Day 0
  • Use of any known CYP3A4 altering drug (i.e., phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids and herbal medications) within 30 days before Day 0. No antibiotics were permitted within 10 days before Day 0
  • Ingestion of grapefruit, grapefruit juice, Seville oranges, or orange marmalade within 2 days of study entry (Day 0)
  • Blood or plasma donations (>100 mL total) for research or altruistic reasons within 30 days before Day 0
  • Seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/minute or >90 beats/minute
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  • History of any illness (including malabsorption, irregular food intake, gastrointestinal intolerance, or allergy) that, in the opinion of the investigator, might confound the results of the study or pose additional risks in administering TPV/r
  • Any acute illness within 2 weeks before Day 0
  • Patients who were currently taking any over-the-counter medication within 7 days before Day 0, or who were currently taking any prescription drug that, in the opinion of the investigator (in consultation with the BI medical monitor or pharmacokineticist), would have interfered with either the absorption, distribution, or metabolism of TPV or ritonavir
  • Hypersensitivity to TPV, ritonavir, or sulfonamide containing drugs, or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
  • Sulfonamide allergy, that in the opinion of the investigator, might confound the results of the study or pose additional risks in administering TPV/r
  • Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator (i.e., aspartate aminotransferase and alanine aminotransferase levels 2.5-fold and 2.5-fold higher than the upper normal limit, respectively)
  • Based on the compliance diary, the patient had less than 100% documented compliance for 7-14 days of background Antiretroviral (ARV) (i.e., ZDV and ABC) medications before Day -5 to 0 (visit 2)
  • Use of any protease inhibitors (i.e., fosamprenavir, amprenavir, indinavir, saquinavir, lopinavir, ritonavir, atazanavir, and nelfinavir) within 6 months of enrollment
  • Patients who are co-infected with active Hepatitis B and/or C as determined by hepatitis serology.
  • Use of any anti-platelet medications (e.g. aspirin, dipyridamole, clopidogrel, or any over the counter anti-platelet medicine).

About this study

Official title: Effect of Steady State TPV/r 500 mg/200 mg on Intracellular Concentrations of Zidovudine Triphosphate and Carbovir Triphosphate

To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate (CBV-TP) and plasma viral load

Conditions
HIV Infections
Being tested
Tipranavir capsules, Ritonavir capsules
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tipranavir capsulesDrug

  • Ritonavir capsulesDrug

Study groups in NCT02229760
Study groupRoleWhat they receive
TPV/r (Tipranavir co-administered with low dose ritonavir)ExperimentalNot described
Receives: Drug: Tipranavir capsules; Drug: Ritonavir capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-12h (Area under curve) of intracellular ZDV-TP

    Measured: Up to 12 hours after drug administration

  2. AUC0-12h (Area under curve) of carbovir-TP

    Measured: Up to 12 hours after drug administration

Secondary outcomes (12)

  1. Number of patients with clinical significant findings in vital sings

    Measured: Up to 14 days after last drug administration

  2. Number of patients with clinical significant findings in physical examinations

    Measured: Up to 14 days after last drug administration

  3. Number of patients with clinical significant findings in laboratory measurements

    Measured: Up to 14 days after last drug administration

  4. Concentration of Zidovudine (ZDV) in plasma

    Measured: Up to 14 days after drug administration

  5. Concentration of Abacavir (ABC) in plasma

    Measured: Up to 14 days after drug administration

  6. Concentration of Tipranavir (TPV) in plasma

    Measured: Up to 14 days after drug administration

  7. Concentration of ritonavir in plasma

    Measured: Up to 14 days after drug administration

  8. Cmax (Maximum observed concentration)

    Measured: Up to 14 days after drug administration

  9. Cp12h (Trough plasma concentration)

    Measured: Up to 14 days after drug administration

  10. AUC0-12h (Area under curve)

    Measured: Up to 14 days after drug administration

  11. Number of patients with adverse events

    Measured: Up to 14 days after last drug adminnistration

  12. Percentage of patients with viral load (VL) <50

    Measured: Up to 14 days after last drug adminnistration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2014 (estimated)
  2. Study startAug 2006
  3. Primary completionSep 2007

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02229760
Sponsor's protocol ID
1182.109
Status last verified
Aug 2014
First submitted
28 Aug 2014
Last updated
1 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tipranavir capsules and Ritonavir capsules in people with HIV Infections, run by Boehringer Ingelheim.

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 12 inclusion and 16 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 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early. Results are not available in the source record.

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?

AUC0-12h (Area under curve) of intracellular ZDV-TP (time frame: Up to 12 hours after drug administration). 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?

On the ClinicalTrials.gov record for NCT02229760.

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 Sep 2014.

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