Status:
COMPLETED
Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Secondar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02232581
Start Date
April 1 2004
Last Update
September 5 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.