HIV InfectionsPhase 3NCT00025727
Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
A Phase 3 study testing Lopinavir/Ritonavir, Ritonavir and GW433908 in people with HIV Infections, run by GlaxoSmithKline at 32 sites in United States.
Trial summary
The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success. 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?
- Lopinavir/Ritonavir, Ritonavir and GW433908
- How many people
- 330 participants
- Where
- 32 sitesUnited States
- Study dates
- May 2001to 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:
- Have a viral load of 1,000 or more copies/ml.
- Have taken protease inhibitors (PIs).
- Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
- Are now taking antiretroviral therapy.
- Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.
- Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.
Who cannot join
- Patients will not be eligible for this study if they:
- Have taken APV or LPV for more than 1 week.
- Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
- Have taken more than 2 PIs.
- Are unable to take 2 active RTIs, as specified by the study.
- Have an active CDC Category C disease.
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- Have certain abnormal laboratory tests.
- Are pregnant or breast-feeding.
- Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.
- Have a history of significant kidney or bone disease.
- Are not able to take drugs by mouth and cannot absorb them.
- Have had pancreatitis or hepatitis within the previous 6 months.
- Have a drug allergy or other allergy which might cause a problem during the study.
- Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.
- Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.
- Have had any HIV vaccine within 3 months before taking the study drug.
- Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.
- Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.
- Are not able to take the study drugs.
- Have inadequate kidney function.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Summa Health System
Akron, Ohio, 44304
IDC Research Initiative
Altamonte Springs, Florida, 32701
Med College of Georgia
Augusta, Georgia, 30912
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
Bach and Godofsky
Bradenton, Florida, 34205
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, 60612
Denver Inf Disease Consultants
Denver, Colorado, 80220
Duke Univ Med Ctr
Durham, North Carolina, 27710
Community Health Care
Fort Lauderdale, Florida, 33306
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311
Joseph Gathe
Houston, Texas, 77004
Ocean View Internal Medicine
Long Beach, California, 90803
Bisher Akil
Los Angeles, California, 90046
Tower ID Med Associates
Los Angeles, California, 90048
Methodist Healthcare
Memphis, Tennessee, 38104
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404
Gervais Frechette
New York, New York, 10011
Orange Coast Med Group
Newport Beach, California, 92663
Florida ID Group
Orlando, Florida, 32801
Discovery Alliance Inc
Pensacola, Florida, 32503
West Florida Clinical Research Ctr
Pensacola, Florida, 32514
Phoenix Body Positive
Phoenix, Arizona, 85006
Fanno Creek Clinic
Portland, Oregon, 97219
Roger Williams Med Ctr
Providence, Rhode Island, 02908
Virginia Commonwealth Univ
Richmond, Virginia, 23298
Pacific Horizons Med Group
San Francisco, California, 94115
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
ID Care Inc
Somerville, New Jersey, 08876
Southampton Healthcare Inc
St Louis, Missouri, 63139
Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees Township, New Jersey, 08043
Physicans Home Service
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.
Read the detailed description
Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Ritonavir, GW433908
- Keywords
- HIV-1, HIV Protease Inhibitors, Ritonavir, RNA, Viral, Anti-HIV Agents, Viral Load, ABT 378, VX-175
- 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
RitonavirDrug
GW433908Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2001 (estimated)
- Study startMay 2001
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.
- More trials run by GlaxoSmithKlineThe 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
- Intervention model
- Parallel groups
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025727
- Sponsor's protocol ID
- 316C
- Status last verified
- Jun 2002
- First submitted
- 15 Oct 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 Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
- ClinicalTrials.gov ID
- NCT00025727
- Acronym / sponsor ID
- 316C
- Conditions
- HIV Infections
- Keywords
- HIV-1, HIV Protease Inhibitors, Ritonavir, RNA, Viral, Anti-HIV Agents, Viral Load, ABT 378, VX-175
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2001
- First posted
- 16 Oct 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 test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.
Detailed description
Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have a viral load of 1,000 or more copies/ml.
- Have taken protease inhibitors (PIs).
- Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
- Are now taking antiretroviral therapy.
- Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.
Key exclusion criteria (20 listed)
- Have taken APV or LPV for more than 1 week.
- Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
- Have taken more than 2 PIs.
- Are unable to take 2 active RTIs, as specified by the study.
- Have an active CDC Category C disease.
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 | – |
| Ritonavir | 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.
32 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 Lopinavir/Ritonavir, Ritonavir and GW433908 in people with HIV Infections, run by GlaxoSmithKline at 32 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 7 inclusion and 20 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 32 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.