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Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load. | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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 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

NCT00040157•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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.
+1 more criteria

Locations (13)

Body Positive, Inc.

Phoenix, Arizona, United States

Los Angeles, California, United States

Pacific Horizon Medical Group, Inc.

San Francisco, California, United States

Community Health Care Center One, Inc.

Fort Lauderdale, Florida, United States

South Shore Hospital

Miami Beach, Florida, United States

AIDS Research Consortium

Atlanta, Georgia, United States

Chicago, Illinois, United States

St. Lukes Roosevelt Hospital

New York, New York, United States

Stony Brook University Infectious Disease, Dept. of Medicine

Stony Brook, New York, United States

Houston, Texas, United States

Key Dates

Completion Date

May 1, 2003

Last Updated

December 30, 2015

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

ACH126-443 (Beta-L-Fd4C)

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

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