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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002177
• Other study ID #: 244D
• Secondary ID: AI455-063
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: April 13, 2011
• Start date: May 1997
• Est. completion date: March 2000

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 these drugs over CD4 cell counts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2000
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Active alcohol or substance abuse.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Hydroxyurea

• Nelfinavir mesylate

• Stavudine

• Didanosine

Locations

Country	Name	City	State
United States	Univ of California at San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm