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 study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002185
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999
  Purpose

To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Nelfinavir mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 20
Detailed Description:

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002185

Locations
United States, California
LAC and USC Med Ctr / School of Medicine
Los Angeles, California, United States, 90033
Univ of California / UCI Med Ctr
Orange, California, United States, 92868
UCSD Treatment Ctr
San Diego, California, United States, 92103
Santa Clara Valley Med Ctr
San Jose, California, United States, 951282699
Harbor - UCLA Med Ctr - Box 449
Torrance, California, United States, 90509
Sponsors and Collaborators
Agouron Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002185     History of Changes
Other Study ID Numbers: 259F, AG1343-513
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms
AIDS-Related Opportunistic Infections
Sarcoma, Kaposi
Drug Therapy, Combination
HIV Protease Inhibitors
Mucous Membrane
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
HIV Protease Inhibitors
Nelfinavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014