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Infection, Human Immunodeficiency Virus IPhase 3NCT00046176

A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

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 56 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
abacavir/lamivudine, abacavir and lamivudine
How many people
240 participants
Where
56 sitesin 4 countries
Study dates
26 Aug 2002to 17 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

  • Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at least 24 weeks.
  • NOTE: Subjects who have required a change in initial protease inhibitor (PI) or NNRTI therapy due to intolerance (not treatment failure) are eligible. Subject must be on a stable regimen of the second PI or NNRTI therapy for at least 6 months before enrollment in this study.
  • Plasma HIV-1 RNA less than 400 copies/mL for at least 3 months immediately preceding the screening visit, and at screening.
  • CD4+ cell count of at least 50 cells/mm3 at screening.
  • Written informed consent to participate in the study before participation.
  • Male or female (Females of child-bearing potential must have a negative serum pregnancy test at screening and agree to an acceptable method of contraception.)

Who cannot join

  • History of a CDC Clinical Category C event requiring treatment (not including cutaneous Kaposi's sarcoma) within 45 days of the screening visit. Treatment for the acute event must have been completed at least 30 days before screening.
  • Subject is enrolled in one or more investigational drug studies which may impact HIV RNA suppression.
  • Subject is unable to complete the 48-week dosing period, evaluations and assessments.
  • Subject is pregnant or breastfeeding.
  • History of clinically relevant inflammation of the pancreas or hepatitis within 6 months prior to screening.
  • Subject suffers from a serious medical condition, such as diabetes or heart problem.
Show all 14Show fewer
  • Pre-existing mental, physical, or substance abuse disorder.
  • History of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction.
  • Abnormal laboratory results within 28 days before the first dose of study medication.
  • Required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days before screening, or will need these during the study.
  • Subject requires treatment with immunomodulating drugs such as systemic corticosteroids, interleukins, vaccines, or interferons within 28 days prior to screening, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
  • Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.
  • Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of screening.
  • Subject has a history of allergy to any of the study drugs.

Trial locations and contacts

56 sites in 4 countries.

56 sites in 4 countries

United States52 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Atlanta, Georgia, 30339

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • 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

    Dallas, Texas, 75219

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80205

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • 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

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Greenville, North Carolina, 27858

  • GSK Investigational Site

    Hampton, Virginia, 23666

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Houston, Texas, 77027

  • GSK Investigational Site

    Jacksonville, Florida, 32206

  • GSK Investigational Site

    Knoxville, Tennessee, 37916

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90028

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Miami, Florida, 33133

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    New York, New York, 10011

  • GSK Investigational Site

    New York, New York, 10014

  • GSK Investigational Site

    New York, New York, 10019

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Plantation, Florida, 33317

  • GSK Investigational Site

    Reading, Pennsylvania, 19601

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    San Francisco, California, 94115-1931

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Tampa, Florida, 33602

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Torrance, California, 90502

  • GSK Investigational Site

    Tulsa, Oklahoma, 74127

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20009

  • GSK Investigational Site

    Wichita, Kansas, 67214

Other trials in United States

Puerto Rico2 sites

  • GSK Investigational Site

    Ponce, 00731

  • GSK Investigational Site

    Rio Piedras, 925

Other trials in Puerto Rico

Costa Rica1 site

  • GSK Investigational Site

    San José

Other trials in Costa Rica

Panama1 site

  • GSK Investigational Site

    Panama City

Other trials in Panama

About this study

Official title: A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretroviral Experienced Patients.

This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.

Being tested
abacavir/lamivudine, abacavir, lamivudine
Keywords
HIV-1 Abacavir Lamivudine Antiretroviral-experienced
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

    Also called abacavir, abacavir/lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.

    Measured: 48 weeks

Secondary outcomes (1)

  1. Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2002 (estimated)
  2. Study start26 Aug 2002
  3. Primary completion17 May 2004
  4. Study completion17 May 2004

Resources

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
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00046176
Sponsor's protocol ID
ESS30008
Status last verified
Mar 2020
First submitted
20 Sep 2002
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • ABACAVIR + LAMIVUDINE FIXED DOSE COMBINATION TABLET ONCE DAILY (QD) COMPARED WITH ABACAVIR (ABC) AND LAMIVUDINE (3TC) TWICE DAILY (BID) IN HIV-1 INFECTED SUBJECTS (ESS30008). Hill-Zabala, Christina E. PharmD 1, Sosa, Nestor MD 2, DeJesus, Edwin MD 3, Herrera, Gisella MD, Florance, Allison M. MS , Watson, Maria E. PhD , and Shaefer, Mark S. PharmD (144F), 2005 Annual Meeting of the American College of Clinical Pharmacy, San Francisco, CA; USA, 10/23/2005

  • 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

  • Sosa N, DeJesus E, Hill-Zabala C, et al. Abacavir + lamivudine (ABC/3TC) fixed-dose combination tablet once-daily compared with abacavir and lamivudine twice-daily in HIV-1-infected subjects over 48 weeks (ESS30008). 2th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 22-25, 2005. [poster 572]

  • PATIENT SATISFACTION WITH ABACAVIR (ABC)-LAMIVUDINE (3TC) FIXED DOSE COMBINATION (FDC) TABLET ONCE DAILY (QD) COMPARED WITH ABC AND 3TC TWICE DAILY (BID) IN HIV-1 INFECTED PATIENTS (ESS30008). Hill-Zabala, Christina E. PharmD , Watson, Maria E. PhD , Sosa, Nestor MD , DeJesus, Edwin MD , and Florance, Allison M. MS (145E), 2005 Annual Meeting of the American College of Clinical Pharmacy, San Francisco, CA; USA, 10/23/2005

  • Sosa N, Hill-Zabala C, Dejesus E, Herrera G, Florance A, Watson M, Vavro C, Shaefer M. Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL). J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):422-7. doi: 10.1097/01.qai.0000184859.24071.bd.

    PubMed 16280696

  • Sosa N, DeJesus E, Hill-Zabala C, et al. Abacavir + lamivudine (ABC/3TC) fixed-dose combination tablet once-daily compared with abacavir and lamivudine twice-daily in HIV-1-infected subjects (ESS30008). 7th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 14-18, 2004 . [poster P45]

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 56 sites in 4 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 6 inclusion and 14 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 56 sites in United States, Puerto Rico, Costa Rica, Panama. 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?

Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks. (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 NCT00046176, which also lists 6 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.

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