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Antiviral
Tenofovir Disoproxil Fumarate for HIV
N/A
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are at least 18 years old
Patients who have failed treatment with at least 2 protease inhibitors (PIs) or at least 1 PI plus a nonnucleoside reverse transcriptase inhibitor (NNRTI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial makes an unapproved drug available to people with HIV who have few treatment options left and whose disease may worsen.
Who is the study for?
This trial is for HIV-positive adults with a viral load over 10,000 copies/ml and CD4 count of 100 cells/mm3 or lower, or up to 200 cells/mm3 if they had an AIDS-related infection recently. They must have failed treatments with at least two protease inhibitors or one plus a nonnucleoside reverse transcriptase inhibitor and can't be treated effectively with approved anti-HIV drugs.Check my eligibility
What is being tested?
The study provides access to tenofovir disoproxil fumarate (DF) for patients who haven't succeeded with other anti-HIV drug combinations. It aims to offer this medication before it's commercially available to those running out of treatment options due to resistance.See study design
What are the potential side effects?
While the specific side effects are not listed here, tenofovir DF may cause kidney problems; hence individuals taking medications that affect the kidneys were excluded from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have tried at least 2 PIs or 1 PI and 1 NNRTI without success.
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?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,479 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot be effectively treated with existing HIV medications.My CD4 count is 100 or lower, or between 100 and 200 with a recent serious infection.I will use barrier birth control during and for 30 days after the study.I have kidney or bone disease.I am 18 years old or older.My doctor thinks I might not be fit for this study due to my health or medications.I have not taken any medications known to cause kidney problems in the last 7 days.I have tried at least 2 PIs or 1 PI and 1 NNRTI without success.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there available spots for participants in this trial?
"The trial, which was first posted on February 1st 2001 and updated lastly on June 23rd 2005, is not actively enrolling participants at this moment. However, clinicaltrials.gov has noted that 484 other studies are presently recruiting patients to take part in their trials."
Answered by AI
Is this scientific experiment considering elderly participants aged 85 or more?
"The accepted age range for participants of this medical trial is 18-65 years old."
Answered by AI
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