A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection

NCT ID: NCT00002176

Last Updated: 2011-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-05-31
• Study Completion Date: 2000-03-31

Brief 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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Hydroxyurea

Intervention Type: DRUG

Nelfinavir mesylate

Intervention Type: DRUG

Stavudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Locations

Univ of California at San Francisco Gen Hosp

San Francisco, California, United States

Countries

United States

Other Identifiers

AI455-062

Identifier Type: -

Identifier Source: secondary_id

244C

Identifier Type: -

Identifier Source: org_study_id