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New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

NCT ID: NCT00044577

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-16

Study Completion Date

2004-05-25

Brief Summary

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A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

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The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients

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ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

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Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

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Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV

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Detailed Description

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A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.

Conditions

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Infection, Human Immunodeficiency Virus I HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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abacavir/lamivudine

Intervention Type DRUG

abacavir

Intervention Type DRUG

lamivudine

Intervention Type DRUG

tenofovir

Intervention Type DRUG

Other Intervention Names

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lamivudine abacavir/lamivudine abacavir

Eligibility Criteria

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Inclusion Criteria

* Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).
* Patients must be naive to tenofovir.
* HIV-1 RNA level \> 1000 copies/ml on at least one occasion within 21 days of study entry.
* A CD4 cell count \> 50 cells/mm3.
* Specified viral genotypes.

Exclusion Criteria

* Pregnant or breast-feeding women.
* Has an active diagnosis of AIDS.
* Additional qualifying criteria to be determined by the physician.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Oakland, California, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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St Louis, Missouri, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Akron, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Hampton, Virginia, United States

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Seattle, Washington, United States

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Brussels, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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GSK Investigational Site

Garches, , France

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Le Kremlin-Bicêtre, , France

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Levallois-Perret, , France

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Lyon, , France

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Paris, , France

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Munich, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Hamburg, , Germany

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Ferrara, Emilia-Romagna, Italy

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Modena, Emilia-Romagna, Italy

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Brescia, Lombardy, Italy

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Milan, Lombardy, Italy

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Turin, Piedmont, Italy

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Verona, Veneto, Italy

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GSK Investigational Site

Braga, , Portugal

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Cascais, , Portugal

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Coimbra, , Portugal

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GSK Investigational Site

Faro, , Portugal

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GSK Investigational Site

Lisbon, , Portugal

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GSK Investigational Site

Lisbon, , Portugal

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Elche (Alicante), , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Marbella, , Spain

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GSK Investigational Site

Manchester, Lancashire, United Kingdom

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GSK Investigational Site

Thornton Heath, Surrey, United Kingdom

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GSK Investigational Site

London, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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Countries

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United States Belgium Canada France Germany Italy Portugal Spain United Kingdom

References

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EFFICACY AND SAFETY OF A ONCE DAILY FIXED-DOSE COMBINATION OF ABACAVIR/LAMIVUDINE (ABC/3TC) [FDC ] VERSUS ABC TWICE DAILY AND 3TC ONCE DAILY AS SEPARATE ENTITIES [SE] IN ART-EXPERIENCED HIV-1 INFECTED SUBJECTS (CAL30001): 48 WEEK DATA. Clumeck, N., LaMarca, A., Fu, K., Gordon, D., Craig, C., Zhao, H. , Paes, D., and Scott, T. (WePe6.3C13), 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro; Brazil, 7/24/2005

Reference Type RESULT

C Craig, C Stone, T Bonny, K Fu. Similar virology findings in ABC/3TC fixed dose combination (FDC) OAD compared with standard dosing in experienced subjects (CAL30001, ALTO). 7th ICDTHI, Glasgow, UK, 14-18 November 2004. Abstract 98

Reference Type RESULT

Clumeck N, Lamarca A, Fu K, Gordon D, Craig C, Zhao H, Paes D, Scott T. Safety and efficacy of a once daily (OAD) Fixed-Dose Combination (FDC) of ABC/3TC [FDC arm] versus ABC twice daily (BID) and 3TC OAD as separate entities [SE arm] in ART-Experienced HIV-1 Infected Patients. 44th ICAAC, Washington, DC, 30 October-2 November 2004. Abstr. H-558

Reference Type RESULT

Other Identifiers

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CAL30001

Identifier Type: -

Identifier Source: org_study_id

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