A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Hydroxyurea (Drug); Nelfinavir mesylate (Drug); Stavudine (Drug); Didanosine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., ., Principal Investigator, Affiliation: .
Summary
To assess the magnitude and duration of the antiviral activity in plasma and the incidence
and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety
and tolerability of this combination therapy and the magnitude and duration of the effect of
this therapy over CD4 cell counts.
Clinical Details
Official title: A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- Documented HIV infection.
- CD4 count > 500 cells/mm3.
- No HIV-associated symptoms.
- Written, informed consent from parent or legal guardian for patients < 18 years old.
- Availability for follow-up for at least 96 weeks.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
- Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute
therapy at the time of enrollment.
- 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.
Active alcohol or substance abuse.
Locations and Contacts
Univ of California at San Francisco Gen Hosp, San Francisco, California 94110, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: October 1, 2007
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