Infection, Human Immunodeficiency Virus IPhase 3NCT00044577
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
A Phase 3 study testing abacavir/lamivudine, abacavir and lamivudine in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 76 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I, HIV Infection
- What is being tested?
- abacavir/lamivudine, abacavir and lamivudine
- How many people
- 166 participants
- Where
- 76 sitesin 9 countries
- Study dates
- 16 Jul 2002to 25 May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breast-feeding women.
- Has an active diagnosis of AIDS.
- Additional qualifying criteria to be determined by the physician.
Trial locations and contacts
76 sites in 9 countries.
76 sites in 9 countries
United States30 sites
GSK Investigational Site
Akron, Ohio, 44304
GSK Investigational Site
Atlanta, Georgia, 30308/30309
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Columbia, South Carolina, 29206-4713
GSK Investigational Site
Dallas, Texas, 75204
GSK Investigational Site
Dallas, Texas, 75208
GSK Investigational Site
Fort Lauderdale, Florida, 33145
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Jacksonville, Florida, 32206
GSK Investigational Site
Los Angeles, California, 90046
GSK Investigational Site
Miami Beach, Florida, 33140
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
Oakland, California, 94602
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Philadelphia, Pennsylvania, 19102
GSK Investigational Site
Philadelphia, Pennsylvania, 19131
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
St Louis, Missouri, 63108
GSK Investigational Site
Stony Brook, New York, 11794
GSK Investigational Site
Tampa, Florida, 33602
GSK Investigational Site
The Bronx, New York, 10468
Canada8 sites
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Montreal, Quebec, H2L 5B1
GSK Investigational Site
Ottawa, Ontario, K1N 6N5
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5B 1W8
GSK Investigational Site
Toronto, Ontario, M5G 2C4
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6
United Kingdom7 sites
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, SE5 9RS
GSK Investigational Site
London, SW10 9TH
GSK Investigational Site
London, SW17 0QT
GSK Investigational Site
London, W2 1NY
GSK Investigational Site
Manchester, Lancashire, M8 5RB
GSK Investigational Site
Thornton Heath, Surrey, CR7 7YE
Italy6 sites
GSK Investigational Site
Brescia, Lombardy, 25125
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Modena, Emilia-Romagna, 41100
GSK Investigational Site
Turin, Piedmont, 10149
GSK Investigational Site
Verona, Veneto, 37135
Portugal6 sites
GSK Investigational Site
Braga, 4700-308
GSK Investigational Site
Cascais, 2750
GSK Investigational Site
Coimbra, 3000-075
GSK Investigational Site
Faro, 8000-386
GSK Investigational Site
Lisbon, 1769-001
GSK Investigational Site
Lisbon
Spain6 sites
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 8400
GSK Investigational Site
Elche (Alicante), 03202
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Marbella, 29600
France5 sites
GSK Investigational Site
Garches, 92380
GSK Investigational Site
Le Kremlin-Bicêtre, 94275
GSK Investigational Site
Levallois-Perret, 92300
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Paris, 75651
Germany5 sites
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Hamburg, 20099
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Munich, Bavaria, 80335
Belgium3 sites
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
About this study
Official title: 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.
Read the 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.
- Being tested
- abacavir/lamivudine, abacavir, lamivudine, tenofovir
- Keywords
- HIV-1 Abacavir Lamivudine Tenofovir
- Medical subject headings
- Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abacavir/lamivudineDrug
abacavirDrug
lamivudineDrug
tenofovirDrug
Also called lamivudine, abacavir/lamivudine, abacavir
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
Measured: 48 weeks
Secondary outcomes (1)
Viral load response T-cell count Health Outcomes Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2002 (estimated)
- Study start16 Jul 2002
- Primary completion25 May 2004
- Study completion25 May 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044577
- Sponsor's protocol ID
- CAL30001
- Status last verified
- Mar 2020
- First submitted
- 30 Aug 2002
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- See Detailed Description
- ClinicalTrials.gov ID
- NCT00044577
- Acronym / sponsor ID
- CAL30001
- Keywords
- HIV-1 Abacavir Lamivudine Tenofovir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2002 (actual)
- Primary completion
- 25 May 2004 (actual)
- Study completion
- 25 May 2004 (actual)
- First posted
- 4 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding women.
- Has an active diagnosis of AIDS.
- Additional qualifying criteria to be determined by the physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abacavir/lamivudine | Drug | – |
| abacavir | Drug | – |
| lamivudine | Drug | – |
| tenofovirAlso: lamivudine, abacavir/lamivudine, abacavir | Drug | – |
Primary outcome
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
Time frame: 48 weeks
1 secondary outcome
Viral load response T-cell count Health Outcomes Resistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Results publicationEFFICACY 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 publicationC 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 publicationClumeck 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
76 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing abacavir/lamivudine, abacavir and lamivudine in people with Infection, Human Immunodeficiency Virus I and HIV Infection, run by ViiV Healthcare at 76 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Canada, United Kingdom, Italy, Portugal and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044577, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.