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

Primary Purpose

Infection, Human Immunodeficiency Virus I, HIV Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
abacavir/lamivudine
abacavir
lamivudine
tenofovir
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus I focused on measuring HIV-1 Abacavir Lamivudine Tenofovir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
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  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Viral load response T-cell count Health Outcomes Resistance

Full Information

First Posted
August 30, 2002
Last Updated
March 20, 2020
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00044577
Brief Title
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
Official Title
See Detailed Description
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2002 (Actual)
Primary Completion Date
May 25, 2004 (Actual)
Study Completion Date
May 25, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus I, HIV Infection
Keywords
HIV-1 Abacavir Lamivudine Tenofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
abacavir/lamivudine
Intervention Type
Drug
Intervention Name(s)
abacavir
Intervention Type
Drug
Intervention Name(s)
lamivudine
Intervention Type
Drug
Intervention Name(s)
tenofovir
Other Intervention Name(s)
lamivudine, abacavir/lamivudine, abacavir
Primary Outcome Measure Information:
Title
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Viral load response T-cell count Health Outcomes Resistance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90046
Country
United States
Facility Name
GSK Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
GSK Investigational Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308/30309
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
GSK Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
GSK Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
GSK Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206-4713
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
GSK Investigational Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 6N5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
GSK Investigational Site
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
GSK Investigational Site
City
Le Kremlin Bicêtre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
GSK Investigational Site
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
GSK Investigational Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80335
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
GSK Investigational Site
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
GSK Investigational Site
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
GSK Investigational Site
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10149
Country
Italy
Facility Name
GSK Investigational Site
City
Verona
State/Province
Veneto
ZIP/Postal Code
37135
Country
Italy
Facility Name
GSK Investigational Site
City
Braga
ZIP/Postal Code
4700-308
Country
Portugal
Facility Name
GSK Investigational Site
City
Cascais
ZIP/Postal Code
2750
Country
Portugal
Facility Name
GSK Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
GSK Investigational Site
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
Country
Portugal
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8400
Country
Spain
Facility Name
GSK Investigational Site
City
Elche (Alicante)
ZIP/Postal Code
03202
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
GSK Investigational Site
City
Marbella
ZIP/Postal Code
29600
Country
Spain
Facility Name
GSK Investigational Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Thornton Heath
State/Province
Surrey
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW10 9TH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Citation
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
Results Reference
result
Citation
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
Results Reference
result

Learn more about this trial

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

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