HIV InfectionsPhase 3NCT00009061
Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
A Phase 3 study testing Ritonavir, Abacavir sulfate and Nelfinavir mesylate in people with HIV Infections, run by Glaxo Wellcome at 37 sites in United States.
Trial summary
The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Abacavir sulfate and Nelfinavir mesylate
- How many people
- 624 participants
- Where
- 37 sitesUnited States
- Study dates
- Nov 2000to 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 13 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 13 years old (consent of parent or guardian needed if under 18).
- Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
- Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
- Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.
Who cannot join
- Patients will not be eligible for this study if they:
- Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
- Have an active/acute CDC Category C event.
- Are unable to absorb or take medicines by mouth.
- Are pregnant or breast-feeding.
- Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
Show all 13Show fewer
- Have had pancreatitis or hepatitis within the last 6 months.
- Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
- Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
- Have received an HIV vaccine within 3 months before the study drug will be taken.
- Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
- Have received experimental treatments.
- Have allergies which might interfere with the study, in the opinion of the doctor.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Infectious Disease Consultants
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Med College of Georgia
Augusta, Georgia, 30912
Brigham and Women's Hosp
Boston, Massachusetts, 02115
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 452670405
Burnside Clinic
Columbia, South Carolina, 29206
SMO USA
Conyers, Georgia, 30013
CRI of South Florida
Coral Gables, Florida, 33146
Nicholas Bellos
Dallas, Texas, 75246
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Joseph C Gathe
Houston, Texas, 77004
Indiana Univ Med School
Indianapolis, Indiana, 46202
AIDS Healthcare Foundation
Los Angeles, California, 90027
LAGLC
Los Angeles, California, 90028
North Shore Univ Hosp
Manhasset, New York, 11030
Methodist Healthcare
Memphis, Tennessee, 38104
Univ of Miami Dept of Medicine
Miami, Florida, 33136
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404
Hawthorne Med Associates / PAACA
New Bedford, Massachusetts, 02745
St Lukes - Roosevelt Hosp Ctr
New York, New York, 10019
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
Kaiser Hospital
Sacramento, California, 95825
Park Ctr for Health / Keith Vrhel
San Diego, California, 92103
Infectious Diseases Associates
Sarasota, Florida, 34239
Southampton Healthcare Inc
St Louis, Missouri, 63139
Jeffrey Levenson
St. Petersburg, Florida, 33710
Infectious Disease Research Inst
Tampa, Florida, 33614
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
AIDS Research Alliance
West Hollywood, California, 90069
About this study
Official title: A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects
The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
Read the detailed description
Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Abacavir sulfate, Nelfinavir mesylate, Lamivudine, GW433908
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
Abacavir sulfateDrug
Nelfinavir mesylateDrug
LamivudineDrug
GW433908Drug
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 startNov 2000
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
- 624 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009061
- Sponsor's protocol ID
- 316B
- Other IDs
- APV30002
- Status last verified
- Mar 2002
- First submitted
- 23 Jan 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT00009061
- Acronym / sponsor ID
- 316B
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 624 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Nov 2000
- 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 virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
Detailed description
Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are at least 13 years old (consent of parent or guardian needed if under 18).
- Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
- Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
- Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.
Key exclusion criteria (13 listed)
- Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
- Have an active/acute CDC Category C event.
- Are unable to absorb or take medicines by mouth.
- Are pregnant or breast-feeding.
- Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
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 |
|---|---|---|
| Ritonavir | Drug | – |
| Abacavir sulfate | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Lamivudine | Drug | – |
| GW433908 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ritonavir, Abacavir sulfate and Nelfinavir mesylate in people with HIV Infections, run by Glaxo Wellcome at 37 sites in United States.
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 13 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. 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?
Results are not available in the source record.
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 24 Jun 2005.