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A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection conditions. Clinical Trials Search.org is a website 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 Recent 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 Recent HIV Infection medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection. A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, 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 Recent HIV Infection clinical trial. Participants oftentimes recieve the finest healthcare available for their A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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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 Recent HIV Infection  A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection
A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent 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 these drugs 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 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.
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: 244D; AI455-063
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002177
Other Hiv Infections Studies:
1. A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
2. Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
3. Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection
4. Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
5. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
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A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Recent HIV Infection
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