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HIV InfectionsPhase 2NCT00294372

Phase II Study on the Antiviral Activity and Safety of BILR 355 BS in HIV-1 Infected, NNRTI-treated Patients

A Phase 2 study testing BILR 355 BS in people with HIV Infections, run by Boehringer Ingelheim at 11 sites in Germany.

Terminated

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

Official record
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Trial summary

The general aim is to evaluate the antiviral activity and safety of increasing doses of oral administered RTV-boosted BILR 355 BS (75 mg and 150 mg twice daily) in HIV-1-infected, NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or Lopinavir based HAART-regimen 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?
BILR 355 BS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
11 sitesGermany
Study dates
Feb 2006to Sep 2007
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

  • Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
  • HIV-1 infected males or females >= 18 years of age.
  • History of NNRTI based HAART >= 8 weeks and at least one, but not more than 3 NNRTI-associated resistance mutations by current genotype
  • TPV/r or LPV/r susceptible
  • CD4+ T lymphocyte count >= 100 cells/?l.
  • 7. HIV-1 viral load >= 2000 copies/mL at screening. 8. Karnofsky score >= 70 9. Based on the antiviral resistance profile of the patients virus, the investigator must be able to construct a background HAART treatment regimen (OBR) such that the patient will receive 3 effective ARV drugs, in addition to his study medication.
  • 10. Acceptable screening laboratory values (Visit 1) that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply: Absolute neutrophil count (ANC) >750/mm3 Hemoglobin >= 10 g/dL Platelet count >99,000/mm3 AST, ALT , and alkaline phosphatase < 2.5xULN >= DAIDS Grade 1) Total bilirubin <2.5xULN Serum amylase <1.5xULN 11. Acceptable medical history, as assessed by the investigator, with chest x-ray results and ECG within 1 year of study participation.
  • 12. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system 13. A prior AIDS defining event, excluding mycobacterial and invasive fungal infections, is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection) for at least 12 weeks before screening (Visit 1). Note that prior oral thrush, candida esophagitis and cutaneous candida is acceptable.

Who cannot join

  • The following resistance mutations demonstrated at any time prior to starting trial therapy: V106A and/or Y188L
  • Female patients of child-bearing potential who:
  • have a positive serum pregnancy test at screening or during the study, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception.
  • Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT > DAIDS Grade 1
  • Acute/previous mycobacterial or invasive fungal infection requiring therapy or prophylaxis with drugs interfering with or significantly affected by the cytochrome P450 system
  • Use of investigational medications within 30 days before study entry or during the trial.
Show all 11Show fewer
  • Use of concomitant drugs that may significantly reduce plasma levels of the study medications.
  • Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
  • Patients currently treated with systemic ant-cancer chemotherapy
  • Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator.
  • In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Boehringer Ingelheim Investigational Site

    Berlin

  • Boehringer Ingelheim Investigational Site

    Bochum

  • Boehringer Ingelheim Investigational Site

    Bonn

  • Boehringer Ingelheim Investigational Site

    Erlangen

  • Boehringer Ingelheim Investigational Site

    Frankfurt am Main

  • Boehringer Ingelheim Investigational Site

    Hamburg

  • Boehringer Ingelheim Investigational Site

    Hanover

  • Boehringer Ingelheim Investigational Site

    Heidelberg

  • Boehringer Ingelheim Investigational Site

    Mainz

  • Boehringer Ingelheim Investigational Site

    München

  • Boehringer Ingelheim Investigational Site

    Ulm

Other trials in Germany

About this study

Official title: Randomised, Double-blind, Placebo-controlled 7 Day Monotherapy Phase IIa Study to Evaluate the Antiviral Activity and Safety of Increasing Doses of Oral Administered RTV-boosted BILR 355 BS (75 mg and 150 mg Twice Daily) in HIV-1-infected, NNRTI-experienced Patients, Followed by 28 Day Combination Therapy With Tipranavir or Lopinavir Based HAART-regimen

The general aim is to evaluate the antiviral activity and safety of increasing doses of oral administered RTV-boosted BILR 355 BS (75 mg and 150 mg twice daily) in HIV-1-infected, NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or Lopinavir based HAART-regimen

Conditions
HIV Infections
Being tested
BILR 355 BS, Placebo
Medical subject headings
HIV Infections

What participants receive

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

  • BILR 355 BSDrug

  • PlaceboDrug

What is being measured

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

  1. The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3.

    Measured: day 8

Secondary outcomes (18)

  1. Virologic response at Day 8 and Day 35 using <400 copies/mL and 0.5, 1 and 1.5 log10 reduction in viral load from baseline

    Measured: up to week 5

  2. Change from baseline in viral load at each visit

    Measured: up to week 9

  3. Change from baseline in CD4+ cell counts at each visit

    Measured: up to week 9

  4. Time averaged change from baseline in viral load through Days 8 and 35

    Measured: up to week 5

  5. Number of reverse transcriptase (RT) mutations at baseline

    Measured: up to week 5

  6. Number of NNRTI resistance-associated mutations at baseline (refer to Appendix 10.4)

    Measured: up to week 5

  7. The presence of specific RT mutations (both in the list of NNRTI mutations and not in the list for exploratory purposes) at baseline

    Measured: up to week 5

  8. The inhibitory quotient and minimum measured concentration of the analyte in plasma (Cmin)

    Measured: up to Day 8

  9. Exploration of mutations that emerge with exposure to BILR 355 BS to determine the effect on both viral load and IC50 fold change from reference

    Measured: up to week 5

  10. Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours post-dose (AUC0-12h)

    Measured: up to week 5

  11. Maximum measured concentration of the analyte in plasma (Cmax)

    Measured: up to week 5

  12. Changes in total cholesterol, LDL, HDL and triglycerides from baseline to days 8 and 35

    Measured: up to week 9

  13. Incidence of rash, hepatic events, and CNS adverse events

    Measured: up to week 9

  14. Incidence of any adverse events (treatment related and unrelated)

    Measured: up to week 9

  15. Incidence of laboratory test abnormalities

    Measured: up to week 9

  16. Incidence of serious adverse events (including AIDS-defining events)

    Measured: up to week 9

  17. Incidence of ≥ DAIDS 2 Grade elevation in ALT/AST

    Measured: up to week 9

  18. Incidence of AEs leading to discontinuation from the study

    Measured: up to week 9

Timeline

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

  1. First posted22 Feb 2006 (estimated)
  2. Study startFeb 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
36 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00294372
Sponsor's protocol ID
1188.31
Status last verified
Nov 2013
First submitted
20 Feb 2006
Last updated
14 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BILR 355 BS in people with HIV Infections, run by Boehringer Ingelheim at 11 sites in Germany.

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 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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. 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 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?

The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3. (time frame: day 8). 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 NCT00294372.

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 14 Nov 2013.

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