Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure

NCT02232581 | Completed Phase 2

• 1 other identifier: 1211.1
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Mean change in HIV viral load measured from plasma samples

  Up to 4 weeks after drug administration

Secondary Outcomes (12)

• Percentage of virologic responders per treatment arm

  Up to 4 weeks after drug administration

• Proportion of patients experiencing a change of viral load

  Up to 4 weeks after drug administration

• Mean change in CD4+ cell count

  Up to 4 weeks after drug administration

• Percentage of 0.5 virologic responders per treatment arm

  Up to 4 weeks after drug administration

• Percentage of load responders per treatment arm

  Up to 4 weeks after drug administration

Study Arms (4)

Alovudine - low

EXPERIMENTAL

Drug: Alovudine - low; Drug: Placebo

Alovudine - medium

EXPERIMENTAL

Drug: Alovudine - medium; Drug: Placebo

Alovudine - high

EXPERIMENTAL

Drug: Alovudine - high

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Alovudine - low DRUG

Alovudine - low

Alovudine - medium DRUG

Alovudine - medium

Alovudine - high DRUG

Alovudine - high

Placebo DRUG

Alovudine - low; Alovudine - medium; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 5, 2014
• Study Start: April 1, 2004
• Primary Completion: December 1, 2004
• Last Updated: September 5, 2014

Record last verified: 2014-08