Back to resultsStudy to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alovudine - low
Alovudine - medium
Alovudine - high
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent before any trial procedure
- HIV-1 infected males or females ≥18 years of age
- Screening genotypic resistance report indicating two or more of the following nucleoside reverse transcriptase inhibitors (NRTI) resistance mutations: 41, 67, 70, 210 and 215
- Stable NRTI regimen without stavudine and zidovudine for at least 6 weeks before screening and stable antiretroviral (ARV) background treatment for 3 months before screening
- HIV-1 viral load ≥1000 copies/mL and <75,000 copies/mL at screening
- Change in viral load between previous test within 3 months before screening, using local laboratory for routine tests, and screening test was <1.0 log10 copies/mL
- Acceptable medical history, as assessed by the investigator
- Current stable ARV medication regimen between screening (Visit 1) and Visit 2
Exclusion Criteria:
- ARV medication naïve
- Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the previous 3 months
Female patients of child-bearing potential who :
- have a positive serum pregnancy test
- are breast feeding,
- are planning to become pregnant, or
- are not willing to use a barrier method of contraception
- Prior alovudine use
- Use of investigational medications within 30 days before study entry or during the trial
- Use of immunomodulatory drugs within 3 months before study entry or during the trial (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2)
- Current use of rifampin, rifabutine, isoniazid, pyrazinamide, stavudine, zidovudine, ganciclovir, chronic use of hepatotoxic drugs, anti-tumour therapy or probenecid
Laboratory values:
- Neutrophils of Grade 2 or greater abnormality
- Hemoglobin of Grade 2 or greater abnormality
- Platelets: Grade 2 or greater abnormality
- Creatinine of ≥1.25 Upper limit of the normal (ULN)
- Lipase of Grade 1 or greater abnormality
- Alanine aminotransaminase (ALT) or Aspartate aminotransaminase (AST) of Grade 2 or greater abnormality
- Direct bilirubin of Grade 1 or greater abnormality
- CD4 ≤50 cells/mm3
- Hepatitis B (+HBsAg or +HBcAB) or C +Hepatitis C virus (+HCV AB ) co-infection, chronic hepatitis, on-going hepatitis or pancreatitis
- Any new or active AIDS-defining event within 30 days before study entry
- Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator
- In the opinion of the investigator, likely survival of less than 6 months because of underlying disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Alovudine - low
Alovudine - medium
Alovudine - high
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Mean change in HIV viral load measured from plasma samples
Secondary Outcome Measures
Percentage of virologic responders per treatment arm
Proportion of patients experiencing a change of viral load
viral load of ≥1 log10 from baseline to Week 4
Mean change in CD4+ cell count
Percentage of 0.5 virologic responders per treatment arm
Percentage of load responders per treatment arm
Percentage of 0.7 to 0.9 virologic responders per treatment arm
Number of patients with adverse events
Number of patients with laboratory test abnormalities and with respect to Division of AIDS (DAIDS) grading
Number of patients with serious adverse events
Number of patients who discontinued due to adverse event
Mean change in CD8+ cell count
Number of patients with abnormal changes in laboratory parameters
Full Information
NCT ID
NCT02232581
First Posted
September 4, 2014
Last Updated
September 4, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02232581
Brief Title
Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
Official Title
Randomised, Double Blind, Placebo-controlled Dose Ranging Trial to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The primary objective was to determine the mean change in HIV viral load from baseline to Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected patients.
Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety of different doses of alovudine and (2) the effect of baseline nucleoside genotypic susceptibility on virologic response after 4 weeks of alovudine administration
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alovudine - low
Arm Type
Experimental
Arm Title
Alovudine - medium
Arm Type
Experimental
Arm Title
Alovudine - high
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alovudine - low
Intervention Type
Drug
Intervention Name(s)
Alovudine - medium
Intervention Type
Drug
Intervention Name(s)
Alovudine - high
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean change in HIV viral load measured from plasma samples
Time Frame
Up to 4 weeks after drug administration
Secondary Outcome Measure Information:
Title
Percentage of virologic responders per treatment arm
Time Frame
Up to 4 weeks after drug administration
Title
Proportion of patients experiencing a change of viral load
Description
viral load of ≥1 log10 from baseline to Week 4
Time Frame
Up to 4 weeks after drug administration
Title
Mean change in CD4+ cell count
Time Frame
Up to 4 weeks after drug administration
Title
Percentage of 0.5 virologic responders per treatment arm
Time Frame
Up to 4 weeks after drug administration
Title
Percentage of load responders per treatment arm
Time Frame
Up to 4 weeks after drug administration
Title
Percentage of 0.7 to 0.9 virologic responders per treatment arm
Time Frame
Up to 4 weeks after drug administration
Title
Number of patients with adverse events
Time Frame
Up to 4 weeks after drug administration
Title
Number of patients with laboratory test abnormalities and with respect to Division of AIDS (DAIDS) grading
Time Frame
Up to 4 weeks after drug administration
Title
Number of patients with serious adverse events
Time Frame
Up to 4 weeks after drug administration
Title
Number of patients who discontinued due to adverse event
Time Frame
Up to 4 weeks after drug administration
Title
Mean change in CD8+ cell count
Time Frame
Up to 4 weeks after drug administration
Title
Number of patients with abnormal changes in laboratory parameters
Time Frame
Up to 4 weeks after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent before any trial procedure
HIV-1 infected males or females ≥18 years of age
Screening genotypic resistance report indicating two or more of the following nucleoside reverse transcriptase inhibitors (NRTI) resistance mutations: 41, 67, 70, 210 and 215
Stable NRTI regimen without stavudine and zidovudine for at least 6 weeks before screening and stable antiretroviral (ARV) background treatment for 3 months before screening
HIV-1 viral load ≥1000 copies/mL and <75,000 copies/mL at screening
Change in viral load between previous test within 3 months before screening, using local laboratory for routine tests, and screening test was <1.0 log10 copies/mL
Acceptable medical history, as assessed by the investigator
Current stable ARV medication regimen between screening (Visit 1) and Visit 2
Exclusion Criteria:
ARV medication naïve
Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the previous 3 months
Female patients of child-bearing potential who :
have a positive serum pregnancy test
are breast feeding,
are planning to become pregnant, or
are not willing to use a barrier method of contraception
Prior alovudine use
Use of investigational medications within 30 days before study entry or during the trial
Use of immunomodulatory drugs within 3 months before study entry or during the trial (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2)
Current use of rifampin, rifabutine, isoniazid, pyrazinamide, stavudine, zidovudine, ganciclovir, chronic use of hepatotoxic drugs, anti-tumour therapy or probenecid
Laboratory values:
Neutrophils of Grade 2 or greater abnormality
Hemoglobin of Grade 2 or greater abnormality
Platelets: Grade 2 or greater abnormality
Creatinine of ≥1.25 Upper limit of the normal (ULN)
Lipase of Grade 1 or greater abnormality
Alanine aminotransaminase (ALT) or Aspartate aminotransaminase (AST) of Grade 2 or greater abnormality
Direct bilirubin of Grade 1 or greater abnormality
CD4 ≤50 cells/mm3
Hepatitis B (+HBsAg or +HBcAB) or C +Hepatitis C virus (+HCV AB ) co-infection, chronic hepatitis, on-going hepatitis or pancreatitis
Any new or active AIDS-defining event within 30 days before study entry
Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator
In the opinion of the investigator, likely survival of less than 6 months because of underlying disease
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
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