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A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 Clinical research trials and A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3. A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 clinical trial. Test subjects typically receive the most effective healthcare possible for their A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3  A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Agouron Pharmaceuticals ,
Synopsis: To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).
Details: This is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-positivity. - Diagnosed KS proven by biopsy. - NOTE: - Patients must not opt for immediate topical, systemic or radiation treatment. - At least 4 cutaneous lesions not treated within the previous 4 weeks. - Life expectancy > 6 months. - Signed, informed consent from parent or legal guardian for those patients < 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies. - Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS. - Clinically significant malabsorption syndrome. - Renal insufficiency. Patients with any of the following prior conditions are excluded: Significant Fever (> 101 degrees F (38 degrees C) for >= 7 days) and/or diarrhea (> 6 loose stools/day for >= 7 days) within one month of baseline. 1. Immediate topical or systemic treatment for KS lesions. - Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently. Immediate radiation treatment. 1. Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry. - History of > 2 weeks of prior therapy with Indinavir or Ritonavir. - Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry. Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected.
Total Enrollment: 20
Location and Contact Information:
Univ of California / UCI Med Ctr
Orange, California, 92868
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699
United States
LAC and USC Med Ctr / School of Medicine
Los Angeles, California, 90033
United States
Harbor - UCLA Med Ctr - Box 449
Torrance, California, 90509
United States
Additional Information:
Study ID Numbers: 259F; AG1343-513
Study Start Date:
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002185
Other Hiv Infections Studies:
1. A Study of ALRT 1057 Topical Gel in Patients with AIDS-Related Kaposi's Sarcoma
2. Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
3. SU5416 in Patients with AIDS-Related Kaposi's Sarcoma
4. A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma
5. A Phase I Trial of Tecogalan sodium (DS-4152) Administered as an Infusion Every 21 Days
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A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
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