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

March 20, 2020 updated by: ViiV Healthcare

See Detailed Description

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liege, Belgium, 4000
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5B 1W8
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2L 5B1
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • GSK Investigational Site
  • France
      • Garches, France, 92380
        • GSK Investigational Site
      • Le Kremlin Bicêtre Cedex, France, 94275
        • GSK Investigational Site
      • Levallois-Perret, France, 92300
        • GSK Investigational Site
      • Lyon Cedex 03, France, 69437
        • GSK Investigational Site
      • Paris Cedex 13, France, 75651
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 20099
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Germany, 80335
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44100
        • GSK Investigational Site
      • Modena, Emilia-Romagna, Italy, 41100
        • GSK Investigational Site
    • Lombardia
      • Brescia, Lombardia, Italy, 25125
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Italy, 10149
        • GSK Investigational Site
    • Veneto
      • Verona, Veneto, Italy, 37135
        • GSK Investigational Site
  • Portugal
      • Braga, Portugal, 4700-308
        • GSK Investigational Site
      • Cascais, Portugal, 2750
        • GSK Investigational Site
      • Coimbra, Portugal, 3000-075
        • GSK Investigational Site
      • Faro, Portugal, 8000-386
        • GSK Investigational Site
      • Lisboa, Portugal, 1769-001
        • GSK Investigational Site
      • Lisboa, Portugal
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 8400
        • GSK Investigational Site
      • Elche (Alicante), Spain, 03202
        • GSK Investigational Site
      • Madrid, Spain, 28047
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Marbella, Spain, 29600
        • GSK Investigational Site
  • United Kingdom
      • London, United Kingdom, SW10 9TH
        • GSK Investigational Site
      • London, United Kingdom, SE5 9RS
        • GSK Investigational Site
      • London, United Kingdom, NW3 2QG
        • GSK Investigational Site
      • London, United Kingdom, SW17 0QT
        • GSK Investigational Site
      • London, United Kingdom, W2 1NY
        • GSK Investigational Site
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M8 5RB
        • GSK Investigational Site
    • Surrey
      • Thornton Heath, Surrey, United Kingdom, CR7 7YE
        • GSK Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90046
        • GSK Investigational Site
      • Oakland, California, United States, 94602
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33145
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33901
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32206
        • GSK Investigational Site
      • Miami Beach, Florida, United States, 33140
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Plantation, Florida, United States, 33317
        • GSK Investigational Site
      • Tampa, Florida, United States, 33602
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30339
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30308/30309
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10468
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19131
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29206-4713
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75208
        • GSK Investigational Site
      • Dallas, Texas, United States, 75204
        • GSK Investigational Site
    • Virginia
      • Hampton, Virginia, United States, 23666
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Viral load response T-cell count Health Outcomes Resistance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2002

Primary Completion (Actual)

May 25, 2004

Study Completion (Actual)

May 25, 2004

Study Registration Dates

First Submitted

August 30, 2002

First Submitted That Met QC Criteria

September 3, 2002

First Posted (Estimate)

September 4, 2002

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAL30001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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