HIV InfectionsPhase 2NCT02232581
Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
A Phase 2 study testing Alovudine - low, Alovudine - medium and Alovudine - high in people with HIV Infections, run by Boehringer Ingelheim.
Trial 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. 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?
- Alovudine - low, Alovudine - medium and Alovudine - high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Dec 2004
- 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 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
Who cannot join
- 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
Show all 24Show fewer
- 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
About this study
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
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
- Being tested
- Alovudine - low, Alovudine - medium, Alovudine - high, 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.
Alovudine - lowDrug
Alovudine - mediumDrug
Alovudine - highDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Alovudine - low | Experimental | Not described Receives: Drug: Alovudine - low; Drug: Placebo |
| Alovudine - medium | Experimental | Not described Receives: Drug: Alovudine - medium; Drug: Placebo |
| Alovudine - high | Experimental | Not described Receives: Drug: Alovudine - high |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HIV viral load measured from plasma samples
Measured: Up to 4 weeks after drug administration
Secondary outcomes (12)
Percentage of virologic responders per treatment arm
Measured: Up to 4 weeks after drug administration
Proportion of patients experiencing a change of viral load
viral load of ≥1 log10 from baseline to Week 4
Measured: Up to 4 weeks after drug administration
Mean change in CD4+ cell count
Measured: Up to 4 weeks after drug administration
Percentage of 0.5 virologic responders per treatment arm
Measured: Up to 4 weeks after drug administration
Percentage of load responders per treatment arm
Measured: Up to 4 weeks after drug administration
Percentage of 0.7 to 0.9 virologic responders per treatment arm
Measured: Up to 4 weeks after drug administration
Number of patients with adverse events
Measured: Up to 4 weeks after drug administration
Number of patients with laboratory test abnormalities and with respect to Division of AIDS (DAIDS) grading
Measured: Up to 4 weeks after drug administration
Number of patients with serious adverse events
Measured: Up to 4 weeks after drug administration
Number of patients who discontinued due to adverse event
Measured: Up to 4 weeks after drug administration
Mean change in CD8+ cell count
Measured: Up to 4 weeks after drug administration
Number of patients with abnormal changes in laboratory parameters
Measured: Up to 4 weeks after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startApr 2004
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232581
- Sponsor's protocol ID
- 1211.1
- Status last verified
- Aug 2014
- First submitted
- 4 Sep 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02232581
- Acronym / sponsor ID
- 1211.1
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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 :
- Prior alovudine use
- Use of investigational medications within 30 days before study entry or during the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alovudine - low | Drug | Alovudine - low |
| Alovudine - medium | Drug | Alovudine - medium |
| Alovudine - high | Drug | Alovudine - high |
| Placebo | Drug | Alovudine - low, Alovudine - medium, Placebo |
Primary outcome
Mean change in HIV viral load measured from plasma samples
Time frame: Up to 4 weeks after drug administration
12 secondary outcomes
Percentage of virologic responders per treatment arm
Time frame: Up to 4 weeks after drug administration
Proportion of patients experiencing a change of viral load
Time frame: Up to 4 weeks after drug administration
Mean change in CD4+ cell count
Time frame: Up to 4 weeks after drug administration
Percentage of 0.5 virologic responders per treatment arm
Time frame: Up to 4 weeks after drug administration
Percentage of load responders per treatment arm
Time frame: Up to 4 weeks after drug administration
Percentage of 0.7 to 0.9 virologic responders per treatment arm
Time frame: Up to 4 weeks after drug administration
Number of patients with adverse events
Time frame: Up to 4 weeks after drug administration
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
Number of patients with serious adverse events
Time frame: Up to 4 weeks after drug administration
Number of patients who discontinued due to adverse event
Time frame: Up to 4 weeks after drug administration
Mean change in CD8+ cell count
Time frame: Up to 4 weeks after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: Up to 4 weeks after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alovudine - low, Alovudine - medium and Alovudine - high in people with HIV Infections, run by Boehringer Ingelheim.
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 24 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: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in HIV viral load measured from plasma samples (time frame: Up to 4 weeks after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2014.