NCT00294372|TerminatedPhase 2

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

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

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

1188.31

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2006

StartedFeb 2006

Brief 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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach

1 country

11 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed

Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

February 20, 2006

Last Update Submit

November 13, 2013

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (18)

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
up to week 5
Change from baseline in viral load at each visit
up to week 9
Change from baseline in CD4+ cell counts at each visit
up to week 9
Time averaged change from baseline in viral load through Days 8 and 35
up to week 5
Number of reverse transcriptase (RT) mutations at baseline
up to week 5
+13 more secondary outcomes

Interventions

BILR 355 BSDRUG

PlaceboDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
\. 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.
\. 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.
\. 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.

You may not qualify if:

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.
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.

Contact the study team to confirm eligibility.