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
13 Years
N/A
Both
Sarcoma, Kaposi, HIV Infections
Trial Information
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
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
259F
NCT ID:
NCT00002185
Start Date:
Completion Date:
Related Keywords:
- Sarcoma, Kaposi
- HIV Infections
- Skin Neoplasms
- AIDS-Related Opportunistic Infections
- Sarcoma, Kaposi
- Drug Therapy, Combination
- HIV Protease Inhibitors
- Mucous Membrane
- Nelfinavir
- Anti-HIV Agents
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Sarcoma, Kaposi
- Sarcoma
Name | Location |
|---|---|
| LAC and USC Med Ctr / School of Medicine | Los Angeles, California 90033 |
| Univ of California / UCI Med Ctr | Orange, California 92868 |
| UCSD Treatment Ctr | San Diego, California 92103 |
| Santa Clara Valley Med Ctr | San Jose, California 951282699 |
| Harbor - UCLA Med Ctr - Box 449 | Torrance, California 90509 |
