Clareo Health | A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have the following symptoms and conditions:
Treatment naive.
Recent HIV infection.
Baseline laboratory values within acceptable ranges.
Written, informed consent from parent or legal guardian for patients \< 18 years old.
Available for follow-up for at least 96 weeks.
You may not be if
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Documentation of other cause for previously mentioned clinical conditions.
Intractable diarrhea.
Signs and symptoms of bilateral peripheral neuropathy \>= Grade 2.
Inability to tolerate oral medication.
Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.
No other anti-HIV therapy allowed.
Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).
1\. Any prior antiretroviral therapy.
Prior vaccination with a candidate HIV therapeutic vaccine.
Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.
