HIV InfectionsPhase 3NCT00004581
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
A Phase 3 study testing Lopinavir/Ritonavir and Nevirapine in people with HIV Infections, run by Abbott at 88 sites in 14 countries.
Trial summary
The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). 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 and Nevirapine
- How many people
- 300 participants
- Where
- 88 sitesin 14 countries
- Study dates
- Start not givento 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
- Patients may be eligible for this study if they:
- Are at least 12 years old.
- Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
- Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
- Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
- Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.
Who cannot join
- Patients will not be eligible for this study if they:
- Have an active illness.
- Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
- Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
- Have received treatment with a PI other than their current PI.
- Are receiving chemotherapy for cancer.
- Are pregnant or breast-feeding.
Trial locations and contacts
88 sites in 14 countries.
88 sites in 14 countries
United States46 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
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Pacific Oaks Med Group
Beverly Hills, California, 90211
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Med Ctr
Boston, Massachusetts, 02118
Community Research Initiative of New England
Brookline, Massachusetts, 02445
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
Cook County Hosp
Chicago, Illinois, 60612
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
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
Univ of Texas / Med Branch at Galveston
Galveston, Texas, 775550835
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
Univ of Miami School of Medicine
Miami, Florida, 33136
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407
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
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, 07102
St Michaels Med Ctr
Newark, New Jersey, 07102
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Stephen Hauptman
Philadelphia, Pennsylvania, 19107
Phoenix Body Positive
Phoenix, Arizona, 85016
Oregon Health Sciences Univ
Portland, Oregon, 972109951
The Miriam Hosp
Providence, Rhode Island, 02906
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, 84108
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
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
Canada7 sites
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
Montreal Chest Institute
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Sunnybrook Health Science Ctr
Toronto, Ontario
Toronto Gen Hosp
Toronto, Ontario
Saint Paul's Hosp
Vancouver, British Columbia
Germany6 sites
EPIMED
Berlin
Univ Zu Koeln
Cologne
Heinrich Heine Universitat
Düsseldorf
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt
Allgemeines Krankenhaus St Georg
Hamburg
Aids Study Group Mannheim
Mannheim
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
France4 sites
CHU De Bicetre
Paris
Groupe Hospitalier Bichat-Claude Bernard
Paris
Hopital Gustave Dron
Tourcoing
Hopital Paul Brousse
Villejuif
United Kingdom4 sites
Brighton Gen Hosp
Brighton
Chelsea and Westminster Hosp
London
Imperial College School of Medicine
London
Royal Free Hosp
London
Denmark3 sites
Righospitalet
Copenhagen
Hvidovre Univ Hosp
Hvidovre
Odense Univ Hosp
Odense C
About this study
Official title: A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).
Read the detailed description
Patients receive 1 of the following:
- ABT-378/RTV plus NVP plus 2 NRTIs; or
- Investigator-selected PI(s) plus NVP plus 2 NRTIs.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Nevirapine
- Keywords
- Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 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
NevirapineDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004581
- Sponsor's protocol ID
- 285D
- Other IDs
- M98-888
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 20 Feb 2009
- Results posted
- No
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, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00004581
- Acronym / sponsor ID
- 285D
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, ABT 378
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- 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 compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).
Detailed description
Patients receive 1 of the following:
- ABT-378/RTV plus NVP plus 2 NRTIs; or
- Investigator-selected PI(s) plus NVP plus 2 NRTIs.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 12 years old.
- Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
- Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
- Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
- Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.
Key exclusion criteria (8 listed)
- Have an active illness.
- Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
- Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
- Have received treatment with a PI other than their current PI.
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 | – |
| Nevirapine | 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
88 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 and Nevirapine in people with HIV Infections, run by Abbott at 88 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 6 inclusion and 8 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 88 sites in United States, Canada, Germany, Spain, Brazil 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?
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.