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Nucleoside Reverse Transcriptase Inhibitor
Videx Formulations for HIV
Phase 3
Waitlist Available
Research Sponsored by PharmaResearch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be taking a stable Videx-containing anti-HIV regimen, using Videx tablets either once or twice a day, for at least 2 weeks prior to the screening visit
Patients must be HIV-positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare the stomach and intestine side effects of two different forms of Videx in HIV-infected patients.
Who is the study for?
This trial is for HIV-positive adults at least 16 years old who have been on a stable Videx-based anti-HIV regimen for two weeks and experience specific gastrointestinal symptoms. They must commit to an 8-week study period and use effective birth control. Excluded are pregnant or breastfeeding individuals, those with certain gastrointestinal diseases, severe diarrhea, or taking conflicting medications.Check my eligibility
What is being tested?
The study compares the side effects of two forms of Videx: traditional tablets versus a capsule form called Videx EC that may reduce stomach issues and requires fewer daily doses. The goal is to determine if the once-daily capsule leads to fewer gastrointestinal problems in HIV-infected patients.See study design
What are the potential side effects?
Potential side effects include abdominal pain, nausea, vomiting, borborygmus (stomach rumbling), abdominal distension (bloating), loose stools, risk of pancreatitis or gallstones. Side effects might be less frequent or severe with the capsule form compared to the tablet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable HIV treatment with Videx for at least 2 weeks.
Select...
I am HIV-positive.
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?
PharmaResearchLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently on experimental HIV drugs or in a clinical trial for them, except for Phase IV studies.I am currently taking Videx in liquid form, nelfinavir, or amprenavir.I have an active gastrointestinal condition like Crohn's or ulcer.I have not been treated for a serious infection related to AIDS in the last 4 weeks.I cannot take medications orally.I have a condition or past treatment that may affect this study.I have been on a stable HIV treatment with Videx for at least 2 weeks.I have scored 2 or higher for symptoms like abdominal pain or nausea in my first 2 study visits.I am experiencing severe diarrhea.I am at least 16 years old and have consent if under 18.I have had pancreatitis or gallstones in the past.I am HIV-positive.I am currently receiving or planning to start chemotherapy for my cancer.You regularly drink too much alcohol or take drugs that could make you more likely to develop pancreatitis.
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.
Does this research project exclude elderly participants?
"This trial is enrolling candidates who are older than 16 years of age and under 80 years old."
Answered by AI
Who might be most benefited by participating in this clinical trial?
"Eligible participants for this study must be between the ages of 16 and 80, have an HIV infection, and meet other basic criteria. Up to 200 patients will be accepted in total."
Answered by AI
Does the FDA consider this medication to be a safe and effective treatment?
"There is some evidence from previous clinical trials to support the efficacy of this treatment, as well as multiple rounds of data that suggest that it is safe. Therefore, our team has given it a safety score of 3."
Answered by AI
Where are the sites of this research study?
"There are a total of 15 clinical sites participating in this study. While the specific locations are Detroit, Huntersville and St. Louis Park, other cities have been selected to help minimize travel demands for participants."
Answered by AI
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