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HIV InfectionsPhase 2NCT02239835

Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients

A Phase 2 study testing Tipranavir (TPV) low dose, Tipranavir (TPV) high dose and Ritonavir low dose 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

Objectives of the study were to evaluate the efficacy and safety of two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two different doses of TPV in combination with RTV… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Tipranavir (TPV) low dose, Tipranavir (TPV) high dose and Ritonavir low dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
No sites listed yet
Study dates
Dec 1999to Nov 2001
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical failure while on the current PI-containing regimen of indinavir, nelfinavir, or amprenavir
  • In the investigator's opinion, adherence to the present PI-containing regimen
  • Exposure of >=6 months to the current PI therapy
  • Stable PI-containing regimen, i.e., receiving the current two reverse transcriptase inhibitors (RTIs) for at least 2 months prior to study entry
  • HIV-1 RNA >=1000 copies/mL (assayed using the Amplicor polymerase chain reaction (PCR) method at the initial screening visit)
  • No limit in CD4+ cell count at the initial screening
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  • At least two new nucleoside reverse transcriptase inhibitor (NRTI) options available
  • Age >=18 years
  • Acceptable screening laboratory test values that indicated adequate baseline organ function at the time of screening. Acceptable laboratory test values consisted of the following: severity <=Grade 1 (ACTG Grading Scale). Stable Grade 2 abnormalities were permitted if the values had been demonstrated and documented for at least >=2 months. All laboratory values >Grade 2 were subject to approval by the P\&U Clinical Program Leader or designated personnel and subsequently by the BI designated personnel
  • Acceptable medical history, physical examination, ECG, and chest radiograph prior to entry into the treatment phase of the study
  • Use of a barrier contraceptive method of birth control for at least 30 days prior to study drug administration, during the study, and 30 days after study completion
  • Ability to swallow numerous tablets and capsules without difficulty
  • Ability to understand and provide informed consent. Minors had to have approval of a parent or legal guardian

Who cannot join

  • Treatment with more than one PI-containing regimen
  • Clinically significant active or acute (onset within the month previous to study entry) medical problems, including the following: opportunistic infections, e.g., active cryptococcosis, Pneumocystis carinii pneumonia, herpes zoster, histoplasmosis, or cytomegalovirus; nonopportunistic diseases, including but not limited to the following: progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
  • Prior exposure (>7 days) to tipranavir, saquinavir, or ritonavir
  • History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair adherence to the protocol
  • Taking of any known P450 3A enzyme-inducing drugs within 30 days of study entry and including the following: rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfadimidine, sulfinpyrazone, or troleandomycin
  • Hypersensitivity to tipranavir, saquinavir, or ritonavir
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  • Use of interferons, interleukins, HIV vaccines, or any active immunizations within 30 days of study entry
  • Taking of any investigational medication with the exception of adefovir dipivoxil (Preveon™) within 30 days of study entry
  • Pregnancy or lactation (serum β-human chorionic gonadotrophin test had to have been negative within 14 days of study entry)
  • Evidence of substance abuse, which in the investigator's opinion could affect adherence to the protocol
  • In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified

About this study

Official title: Tipranavir: An Open-label, Randomized Study Comparing Combination Therapy (Tipranavir and Ritonavir vs. Saquinavir and Ritonavir) Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients

Objectives of the study were to evaluate the efficacy and safety of two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two different doses of TPV in combination with RTV for efficacy and safety.

Conditions
HIV Infections
Being tested
Tipranavir (TPV) low dose, Tipranavir (TPV) high dose, Ritonavir low dose, Ritonavir high dose, Saquinavir
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 (TPV) low doseDrug

  • Tipranavir (TPV) high doseDrug

  • Ritonavir low doseDrug

  • Ritonavir high doseDrug

  • SaquinavirDrug

Study groups in NCT02239835
Study groupRoleWhat they receive
TPV low dose + RTV low doseExperimentalNot described
Receives: Drug: Tipranavir (TPV) low dose; Drug: Ritonavir low dose
TPV high dose + RTV low doseExperimentalNot described
Receives: Drug: Tipranavir (TPV) high dose; Drug: Ritonavir low dose
SQV + RTV high doseActive comparatorNot described
Receives: Drug: Ritonavir high dose; Drug: Saquinavir

What is being measured

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

  1. Change from baseline in plasma HIV-1 RNA concentrations

    Measured: Week 16, 24 and 48

  2. Occurrence of HIV-1 RNA levels below the limit of quantitation (BLQ)

    using the Roche Amplicor HIV Monitor™ Method [limit of detection (LD) 400 copies/mL] and the Roche Amplicor UltraSensitive Method™ (LD 50 copies/mL)

    Measured: up to 96 weeks

  3. Number of patients with treatment-emergent and drug-related adverse events (AEs)

    Measured: up to 96 weeks

  4. Number of patients with serious adverse events (SAEs)

    Measured: up to 96 weeks

  5. Number of patients with grade 3 and 4 laboratory abnormalities

    Measured: up to 96 weeks

Secondary outcomes (15)

  1. Change from baseline in cluster of differentiation (CD) 4+ cell count

    Measured: Week 16, 24 and 48

  2. Time to virologic failure

    defined as plasma HIV-1 RNA values >400 copies/mL at two consecutive time points 2 to 4 weeks apart

    Measured: after week 16

  3. Occurrence of new or recurring AIDS-defining illnesses

    Measured: up to 96 weeks

  4. Occurrence of HIV-1 related illness

    Measured: up to 96 weeks

  5. Occurrence of death

    Measured: up to 96 weeks

  6. Time to new or recurring AIDS-defining illnesses

    Measured: up to 96 weeks

  7. Time to HIV-1 related illness

    Measured: up to 96 weeks

  8. Time to death

    Measured: up to 96 weeks

  9. Change from baseline in blood glucose

    Measured: up to 96 weeks

  10. Change from baseline in cholesterol

    Measured: up to 96 weeks

  11. Change from baseline in high density lipoprotein (HDL)

    Measured: up to 96 weeks

  12. Change from baseline in triglycerides

    Measured: up to 96 weeks

  13. Time to virologic response

    Measured: up to 96 weeks

  14. Trough plasma tipranavir concentrations

    Measured: up to week 24

  15. Sequence-based HIV-1 analysis (genotyping) and drug susceptibility assays (phenotyping)

    Measured: Baseline and week 24

Timeline

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

  1. First posted15 Sep 2014 (estimated)
  2. Study startDec 1999
  3. Primary completionNov 2001

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02239835
Sponsor's protocol ID
1182.4
Status last verified
Sep 2014
First submitted
11 Sep 2014
Last updated
15 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tipranavir (TPV) low dose, Tipranavir (TPV) high dose and Ritonavir low dose 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 13 inclusion and 11 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 15 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 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 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?

Change from baseline in plasma HIV-1 RNA concentrations (time frame: Week 16, 24 and 48). The study lists 5 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 NCT02239835.

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 15 Sep 2014.

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