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Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) Clinical research trials and Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune). Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)  Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)
Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)
For Condition: HIV Infections
Status: Completed
Sponsor(s): Agouron Pharmaceuticals ,
Synopsis: The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood (viral load).
Details: At the time of study entry, all patients are receiving a HAART regimen consisting of three drugs from at least two classes of antiretroviral drugs. Upon entering the study, patients receive Remune or IFA at Weeks 0, 12, and 24. Patients remain on study for 40 weeks. Patients who have received three injections of Remune or IFA and whose plasma HIV-1 RNA level is less than 50 copies/ml at Week 26 discontinue HAART at Week 28. (If the patient has a plasma HIV-1 RNA level at or above 50 copies/ml at Week 26, he/she must have a measurement below 50 copies/ml at Week 27 to proceed with HAART discontinuation at Week 28. If by Week 27 the patient does not have a plasma HIV-1 RNA level below 50 copies/ml, the patient does not discontinue HAART but remains on study and has study visits at Weeks 34 and 40.) Patients who discontinue HAART have their plasma HIV-1 RNA levels measured on the day HAART is discontinued and at Days 3, 5, 7, 10, 14, 21, 28, 35, and 42 after discontinuation. Patients with a plasma HIV-1 RNA level of at least 5,000 copies/ml at Week 34 restart HAART at that time. (Patients whose plasma HIV-1 RNA level reaches greater than or equal to 100,000 copies/ml on two occasions before Week 34 have the option of restarting HAART immediately.) Patients whose plasma HIV-1 RNA level is less than 5,000 copies/ml at Week 34 do not restart HAART unless their level increases to at least 5,000 copies/ml. Patients who discontinue HAART are monitored intensively for the duration of the study. Patients have 27 visits if they stay on study until completion at Week 40.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are receiving an anti-HIV drug combination that contains three drugs from at least two classes of anti-HIV drugs (such as protease inhibitors). Patients must have been receiving this drug combination for at least 6 months before study entry. Before beginning this drug combination, patients must have taken either no anti-HIV drugs or only one or two nucleoside analogues (NRTIs). - Had a viral load between 5,000 and 100,000 copies/ml before beginning their current anti-HIV therapy. - Have a viral load below 50 copies/ml while on their current anti-HIV therapy within 2 weeks before study entry. - Have a CD4 count greater than 350 cells/mm3 at the time of study entry. - Are at least 13 years old (consent of parent or guardian required if under 18).
Total Enrollment: 40
Location and Contact Information:
Agouron Pharmaceuticals Inc
San Diego, California, 92121
United States
Additional Information:
Study ID Numbers: B008; AG1661-201
Study Start Date:
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005001
Other Hiv Infections Studies:
1. Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients with CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Have Received Antiretroviral Treatment
2. A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC
3. An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3
4. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
5. A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-phosphonylmethoxypropyl)cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Safety and Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)
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