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NCT00044577 Clinical Trial

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

HIV Infection Clinical Trial

Official title:
See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00044577
Other study ID # CAL30001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 16, 2002
Est. completion date May 25, 2004

Study information
Verified date March 2020
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date May 25, 2004
Est. primary completion date May 25, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• abacavir/lamivudine

• abacavir

• lamivudine

• tenofovir

Locations
Country Name City State
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Leuven
Belgium GSK Investigational Site Liege
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Ottawa Ontario
Canada GSK Investigational Site Sainte-Foy Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Vancouver British Columbia
France GSK Investigational Site Garches
France GSK Investigational Site Le Kremlin Bicêtre Cedex
France GSK Investigational Site Levallois-Perret
France GSK Investigational Site Lyon Cedex 03
France GSK Investigational Site Paris Cedex 13
Germany GSK Investigational Site Frankfurt Hessen
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Muenchen Bayern
Italy GSK Investigational Site Brescia Lombardia
Italy GSK Investigational Site Ferrara Emilia-Romagna
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena Emilia-Romagna
Italy GSK Investigational Site Torino Piemonte
Italy GSK Investigational Site Verona Veneto
Portugal GSK Investigational Site Braga
Portugal GSK Investigational Site Cascais
Portugal GSK Investigational Site Coimbra
Portugal GSK Investigational Site Faro
Portugal GSK Investigational Site Lisboa
Portugal GSK Investigational Site Lisboa
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Elche (Alicante)
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Marbella
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Manchester Lancashire
United Kingdom GSK Investigational Site Thornton Heath Surrey
United States GSK Investigational Site Akron Ohio
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Augusta Georgia
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Columbia South Carolina
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Hampton Virginia
United States GSK Investigational Site Indianapolis Indiana
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Miami Beach Florida
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site Oakland California
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Plantation Florida
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Stony Brook New York
United States GSK Investigational Site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Portugal,  Spain,  United Kingdom, 

References & Publications (3)

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 H

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., LaMarc

Outcome
Type Measure Description Time frame Safety issue
Primary HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety 48 weeks
Secondary Viral load response T-cell count Health Outcomes Resistance
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