|
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 References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about 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 site 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 happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as 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 volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes 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. Subjects frequently obtain the most expert 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, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
2. Protocol For the Treatment of Cryptosporidiosis in AIDS Patients with Diclazuril (R64,433)
3. A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
4. A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
5. Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Jose Clinical Trials
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
|
|
|
|
|
|
|
|
