Clinical trial NCT00040157: Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Keywords: treatment experienced,
Stable triple anti-retroviral combination therapy in HIV-infected,
Achillion
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Body Positive, Inc.
state: Arizona
city: L.a.
country: United States
state: California
city: San Francisco
country: United States
facility: Pacific Horizon Medical Group, Inc.
state: California
city: Ft. Lauderdale
country: United States
facility: Community Health Care Center One, Inc.
state: Florida
city: Miami Beach
country: United States
facility: South Shore Hospital
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium
state: Georgia
city: Chicago
country: United States
state: Illinois
city: New York
country: United States
facility: St. Lukes Roosevelt Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Infectious Disease, Dept. of Medicine
state: New York
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Hampton
country: United States
facility: Hampton Road Medical Specialists
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: