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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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.
Condition | Intervention |
---|---|
HIV Infections |
Drug: Hydroxyurea Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
![](https://webarchive.library.unt.edu/web/20130317082238im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
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.
![](https://webarchive.library.unt.edu/web/20130317082238im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, California | |
Univ of California at San Francisco Gen Hosp | |
San Francisco, California, United States, 94110 |
Principal Investigator: | . ., . | . |
![](https://webarchive.library.unt.edu/web/20130317082238im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00002176 History of Changes |
Other Study ID Numbers: | 244C, AI455-062 |
Study First Received: | November 2, 1999 |
Last Updated: | April 13, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
Pilot Projects Didanosine Drug Therapy, Combination Stavudine |
Hydroxyurea Nelfinavir Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
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 Didanosine Stavudine Nelfinavir Hydroxyurea |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Antineoplastic Agents Antisickling Agents Hematologic Agents HIV Protease Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013