HIV InfectionsPhase 3NCT00004583
A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
A Phase 3 study testing Lopinavir/Ritonavir, Nelfinavir mesylate and Lamivudine in people with HIV Infections, run by Abbott at 83 sites in 14 countries.
Trial summary
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/Ritonavir, Nelfinavir mesylate and Lamivudine
- How many people
- 660 participants
- Where
- 83 sitesin 14 countries
- Study dates
- Mar 1999to not given
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this trial if you:
- Are HIV positive.
- Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
- Are age 12 or older.
- Agree to practice abstinence or use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this trial if you:
- Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
- Are seriously ill or have an AIDS-related infection.
- Are pregnant or breast-feeding.
- Are taking certain medications.
Trial locations and contacts
83 sites in 14 countries.
83 sites in 14 countries
United States42 sites
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, 481090378
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Emory Univ
Atlanta, Georgia, 30308
Central Texas Med Foundation
Austin, Texas, 78751
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Pacific Oaks Med Group
Beverly Hills, California, 90211
Boston Med Ctr
Boston, Massachusetts, 02118
Community Research Initiative of New England
Brookline, Massachusetts, 02445
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
Oaklawn Physicians Group
Dallas, Texas, 75219
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, 27710
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
Joseph C Gathe
Houston, Texas, 77004
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
AIDS Healthcare Foundation
Los Angeles, California, 900276069
Tower ID Med Associates
Los Angeles, California, 90048
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Wisconsin
Madison, Wisconsin, 53792
Steinhart Medical Associates
Miami, Florida, 33133
Univ of Miami School of Medicine
Miami, Florida, 33136
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510
Tulane Univ Med School
New Orleans, Louisiana, 70112
Beth Israel Med Ctr
New York, New York, 10003
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011
Howard Grossman
New York, New York, 10011
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Stephen Hauptman
Philadelphia, Pennsylvania, 19107
Oregon Health Sciences Univ
Portland, Oregon, 972109951
The Miriam Hosp
Providence, Rhode Island, 02906
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153
Infectious Disease Research Institute
Tampa, Florida, 33614
Harbor - UCLA Med Ctr
Torrance, California, 90502
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
Canada6 sites
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
Montreal Chest Institute
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Toronto Gen Hosp
Toronto, Ontario
Saint Paul's Hosp
Vancouver, British Columbia
Spain6 sites
Hosp Germans Trias I Pujol
Barcelona
Hosp Carlos III
Madrid
Hosp De Mostoles
Madrid
Hosp Doce De Octubre
Madrid
Hosp La Paz
Madrid
Hosp Virgen Del Rocio
Seville
Brazil5 sites
Hosp Evandro Chagas Fioernz
Manguinhos RJ
Castelo
São Paulo
Fundacao Zerbini Casa Da Aids
São Paulo
Hosp Do Servidor Publico Estadual De Sao Paulo
São Paulo
Hosp Heliopolis
São Paulo
Germany5 sites
EPIMED
Berlin
Univ Zu Koeln
Cologne
Heinrich Heine Universitat
Düsseldorf
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt
Allgemeines Krankenhaus St Georg
Hamburg
France4 sites
Centre Hospitalier De Compiegne
Compiègne
CHU De Bicetre
Paris
Groupe Hospitalier Bichat-Claude Bernard
Paris
Hopital Paul Brousse
Villejuif
Australia3 sites
Royal Brisbane Hosp
Herston
Royal Perth Hosp
Perth
Alfred Hosp
Prahan
South Africa3 sites
Miller
Belford Gardens
Cyrildene
Johannesburg
Wits Medical School
Parktown
United Kingdom3 sites
Brighton Gen Hosp
Brighton
Imperial College School of Medicine
London
Royal Free Hosp
London
About this study
Official title: A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).
Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.
Read the detailed description
Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.
Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Nelfinavir mesylate, Lamivudine, Stavudine
- Keywords
- Drug Therapy, Combination, Administration, Oral, Stavudine, HIV Protease Inhibitors, Lamivudine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir, ABT 378
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/RitonavirDrug
Nelfinavir mesylateDrug
LamivudineDrug
StavudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Enrolment
- 660 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004583
- Sponsor's protocol ID
- 285C
- Other IDs
- M98-863
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 20 Feb 2009
- Results posted
- No
Publications
Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.
PubMed 11192874
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00004583
- Acronym / sponsor ID
- 285C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Administration, Oral, Stavudine, HIV Protease Inhibitors, Lamivudine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).
Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.
Detailed description
Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.
Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV positive.
- Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
- Are age 12 or older.
- Agree to practice abstinence or use effective methods of birth control during the study.
Key exclusion criteria (5 listed)
- Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
- Are seriously ill or have an AIDS-related infection.
- Are pregnant or breast-feeding.
- Are taking certain medications.
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 |
|---|---|---|
| Lopinavir/Ritonavir | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Feb 2009.
- Background: PubMed 11192874Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.
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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.
The record lists no contact. Use the official record to reach the sponsor.
83 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lopinavir/Ritonavir, Nelfinavir mesylate and Lamivudine in people with HIV Infections, run by Abbott at 83 sites in 14 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 5 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Canada, Spain, Brazil, Germany and 9 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004583, which also lists 1 linked publication.
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 20 Feb 2009.