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A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection Clinical research trials and A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection. A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection clinical trial. Participants typically obtain the most effective healthcare available for their A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection  A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection
A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: 244C; AI455-062
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002176
Other Hiv Infections Studies:
1. An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
2. Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
3. A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides
4. A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
5. A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
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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