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Protease Inhibitor
GW433908/Ritonavir vs. Lopinavir/Ritonavir for HIV
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have taken protease inhibitors (PIs) for at least 12 straight weeks and have had virologic failure on the PIs
Patients who are currently taking antiretroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test two different drug regimens to see which is more effective in patients who have not had success with other anti-HIV drugs.
Who is the study for?
This trial is for HIV patients who've previously taken protease inhibitors and experienced treatment failure. Participants must have a viral load over 1,000 copies/ml, be at least 13 years old (or meet local age requirements), and if female, not be pregnant and agree to use birth control. Exclusions include those with significant kidney or bone disease, substance abuse issues, certain allergies or serious health conditions.Check my eligibility
What is being tested?
The study compares two dosing regimens of GW433908/ritonavir versus lopinavir/ritonavir when each is combined with two active reverse transcriptase inhibitors in patients who have had unsuccessful anti-HIV treatments.See study design
What are the potential side effects?
Potential side effects may include digestive issues, liver problems like hepatitis or pancreatitis (especially if there's a history), allergic reactions to the drugs involved, changes in blood tests that could indicate other organ issues, fatigue from drug interactions affecting overall health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on protease inhibitors for 12 weeks but they failed to control my virus.
Select...
I am currently on antiretroviral therapy.
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I am at least 13 years old (or 18 if required) and can provide parental consent if under 18.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take or absorb medications orally.I haven't had radiation or chemotherapy in the last 28 days and don't expect to need them during the study.I am currently on antiretroviral therapy.I have been on APV or LPV medication for over a week.I have taken more than 2 protease inhibitors.I cannot take 2 specific HIV medications as required by the study.I have a severe illness defined by the CDC as Category C.I am not pregnant or breastfeeding.I haven't taken excluded drugs in the last 28 days and don't plan to during the study.My kidney function is not normal.I have been on protease inhibitors for 12 weeks but they failed to control my virus.I do not have serious health issues like diabetes, heart problems, or hepatitis.I have not had pancreatitis or hepatitis in the last 6 months.I cannot take the study drugs.I have not received an HIV vaccine in the last 3 months.I have a history of serious kidney or bone disease.I have taken tenofovir or adefovir for my condition.I haven't taken immune-affecting drugs or anti-HIV drugs in the last 28 days.I am currently on antiretroviral therapy.I am at least 13 years old (or 18 if required) and can provide parental consent if under 18.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do we have any octogenarians in the study?
"This trial is recruiting patients who are older than 13 years old and less than 0 years of age."
Answered by AI
Has this medication received government sanctioning?
"Our analysts have determined that this Phase 3 trial's safety merits a score of 3. This is based on supporting efficacy data as well as multiple rounds of data affirming the treatment's safety."
Answered by AI
Who else is applying?
What site did they apply to?
Joseph Gathe
What portion of applicants met pre-screening criteria?
Did not meet criteria
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