A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
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ClinicalTrials.gov Identifier: NCT00002176 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 14, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Hydroxyurea Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | May 1997 |
Actual Primary Completion Date : | March 2000 |
Actual Study Completion Date : | March 2000 |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002176
United States, California | |
Univ of California at San Francisco Gen Hosp | |
San Francisco, California, United States, 94110 |
Principal Investigator: | . ., . |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00002176 History of Changes |
Other Study ID Numbers: |
244C AI455-062 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | April 2011 |
Keywords provided by Bristol-Myers Squibb:
Pilot Projects Didanosine Drug Therapy, Combination Stavudine |
Hydroxyurea Nelfinavir Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Hydroxyurea Nelfinavir |
Stavudine Didanosine Antineoplastic Agents Antisickling Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Antimetabolites Reverse Transcriptase Inhibitors |