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DPC 083 + NRTIs for HIV Infection
Study Summary
This trial will test the safety of DPC 083, an NNRTI, in combination with 2 NRTIs in HIV-infected patients who have failed NNRTI treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
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Who is running the clinical trial?
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- My HIV treatment with a protease inhibitor failed.I have a history of blood clotting issues.I have not used carbamazepine, phenytoin, or St. John's wort in the last 30 days.I agree to use effective birth control methods that are not oral or implantable during and 3 months after the study.I have been on immune-suppressing drugs for more than 2 weeks.I am 18 years old or older.I have had an HIV genotype test while on NNRTI treatment or within 2 weeks after stopping.I have not had any vaccinations in the last 3 weeks.I haven't taken any immune system modifying drugs like interferons or thalidomide in the last 30 days.I have had treatment failure with more than one NNRTI drug.I weigh at least 50 kg.I have not been treated with experimental NNRTIs.My cancer needs treatment that affects my whole body.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the risks associated with this treatment option?
"There is limited data surrounding the safety of this treatment, as it is still in Phase 2 trials. This means that while there have been no reports of efficacy, there have also been no serious safety concerns raised."
Does this research take into account patients that are over 35 years old?
"This trial is only open to patients that are 18 years old or younger. There are a total of 110 studies for patients under the age of eighteen and 367 for patients over the age of sixty-five."
Is this study taking place at a large number of hospitals across America?
"Right now, there are 5 sites where this trial is enrolling patients. The locations are in Los Angeles and Bradenton as well as Tampa with other centres located nearby. If you choose to participate it would be convenient to select the location nearest you to reduce travel time."
How can I become involved in this research project?
"This trial is looking for 30 individuals that are infected with HIV and meet the following criteria: Be between 18-0 years old, weigh a minimum of 50 kg, use an effective barrier method of birth control during the study (oral or skin-based contraceptives can not be the only form of birth control), have a screening HIV genotype done while receiving NNRTI treatment or within 2 weeks after stopping treatment, have documented evidence of virologic failure, and have a viral load of at least 1,000 copies/ml within 45 days prior to Day 1 of the study."
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