Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00040157 |
Recruitment Status
:
Terminated
(Safety concerns)
First Posted
: June 25, 2002
Last Update Posted
: December 30, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: ACH126-443 (Beta-L-Fd4C) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Actual Study Completion Date : | May 2003 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040157
United States, Arizona | |
Body Positive, Inc. | |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
L.a., California, United States | |
Pacific Horizon Medical Group, Inc. | |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Community Health Care Center One, Inc. | |
Ft. Lauderdale, Florida, United States, 33306 | |
South Shore Hospital | |
Miami Beach, Florida, United States, 33160 | |
United States, Georgia | |
AIDS Research Consortium | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, New York | |
St. Lukes Roosevelt Hospital | |
New York, New York, United States, 10019 | |
Stony Brook University Infectious Disease, Dept. of Medicine | |
Stony Brook, New York, United States, 11794-8153 | |
United States, Texas | |
Houston, Texas, United States, 77098 | |
Houston, Texas, United States | |
United States, Virginia | |
Hampton Road Medical Specialists | |
Hampton, Virginia, United States, 23666 | |
United States, Washington | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122 |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00040157 History of Changes |
Other Study ID Numbers: |
ACH443-006 |
First Posted: | June 25, 2002 Key Record Dates |
Last Update Posted: | December 30, 2015 |
Last Verified: | December 2015 |
Keywords provided by Achillion Pharmaceuticals:
treatment experienced, Stable triple anti-retroviral combination therapy in HIV-infected, Achillion |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |