HIV InfectionsPhase 2NCT00040157
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
A Phase 2 study testing ACH126-443 (Beta-L-Fd4C) in people with HIV Infections, run by Alexion Pharmaceuticals, Inc. at 13 sites in United States.
Trial summary
To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC. 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?
- ACH126-443 (Beta-L-Fd4C)
- How many people
- 60 participants
- Where
- 13 sitesUnited States
- Study dates
- Start not givento May 2003
- 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
- Adults ≥18 years of age
- Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)
- Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen
- Plasma HIV RNA level > 1000 and < 30,000 copies/mL on two occasions
- Genotypically documented M184V variant of HIV RT
- Clinically stable HIV status with no AIDS-defining events
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- CD4 > 200 cells/mm3
- Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
- All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication
- No active opportunistic infection requiring treatment
- Subject must be able to provide written informed consent
- Baseline laboratory values measured within 28 days of initiating study drug as follows:
- HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks
- Absolute neutrophil count≥1000 cells/mm(^3) (in the absence of on-going G-CSF therapy
- Platelet count ≥75,000/mm(^3)
- AST <7.0 times the upper limit of normal
- ALT ,7.0 times the upper limit of normal
- Serum creatinine <1.1 times the upper limit of normal
Who cannot join
- Evidence of active HBV infection as demonstrated by HBsAg positivity
- Hepatitis C co-infection
- Concurrent systemic antiviral treatment
- Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
- Alcohol abuse
- Pregnancy or breast-feeding
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- Inability to tolerate oral medication
- AST > 7.0 times the upper limit of normal
- ALT > 7.0 times the upper limit of normal
- Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
- Use of any other drug or substance with anti-HBV activity
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
AIDS Research Consortium
Atlanta, Georgia, 30308
Study site
Chicago, Illinois
Community Health Care Center One, Inc.
Fort Lauderdale, Florida, 33306
Hampton Road Medical Specialists
Hampton, Virginia, 23666
Study site
Houston, Texas, 77098
Study site
Houston, Texas
Study site
Los Angeles, California
South Shore Hospital
Miami Beach, Florida, 33160
St. Lukes Roosevelt Hospital
New York, New York, 10019
Body Positive, Inc.
Phoenix, Arizona, 85006
Pacific Horizon Medical Group, Inc.
San Francisco, California, 94115
Swedish Medical Center
Seattle, Washington, 98122
Stony Brook University Infectious Disease, Dept. of Medicine
Stony Brook, New York, 11794-8153
About this study
Official title: A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple Antiretroviral Combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load
To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.
- Conditions
- HIV Infections
- Being tested
- ACH126-443 (Beta-L-Fd4C)
- Keywords
- treatment experienced,, Stable triple anti-retroviral combination therapy in HIV-infected,, Achillion
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH126-443 (Beta-L-Fd4C)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2002 (estimated)
- Study completionMay 2003
Why it stopped: Safety concerns
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 Alexion Pharmaceuticals, Inc.The 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040157
- Sponsor's protocol ID
- ACH443-006
- Status last verified
- Dec 2015
- First submitted
- 21 Jun 2002
- Last updated
- 30 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple Antiretroviral Combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load
- ClinicalTrials.gov ID
- NCT00040157
- Acronym / sponsor ID
- ACH443-006
- Conditions
- HIV Infections
- Keywords
- treatment experienced,, Stable triple anti-retroviral combination therapy in HIV-infected,, Achillion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 60 participants
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study completion
- May 2003 (actual)
- First posted
- 25 Jun 2002 (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.
To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adults ≥18 years of age
- Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)
- Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen
- Plasma HIV RNA level > 1000 and < 30,000 copies/mL on two occasions
- Genotypically documented M184V variant of HIV RT
Key exclusion criteria (11 listed)
- Evidence of active HBV infection as demonstrated by HBsAg positivity
- Hepatitis C co-infection
- Concurrent systemic antiviral treatment
- Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
- Alcohol abuse
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 |
|---|---|---|
| ACH126-443 (Beta-L-Fd4C) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Related InfoLink provided by the sponsor.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACH126-443 (Beta-L-Fd4C) in people with HIV Infections, run by Alexion Pharmaceuticals, Inc. at 13 sites in United States.
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 18 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Safety concerns). Results are not available in the source record.
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.
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 30 Dec 2015.