search
Back to results

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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Sponsored by
Agouron Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Skin Neoplasms, AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Drug Therapy, Combination, HIV Protease Inhibitors, Mucous Membrane, Nelfinavir, Anti-HIV Agents

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LAC and USC Med Ctr / School of Medicine
  • Univ of California / UCI Med Ctr
  • UCSD Treatment Ctr
  • Santa Clara Valley Med Ctr
  • Harbor - UCLA Med Ctr - Box 449

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Agouron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00002185
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Agouron Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Skin Neoplasms, AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Drug Therapy, Combination, HIV Protease Inhibitors, Mucous Membrane, Nelfinavir, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
LAC and USC Med Ctr / School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ of California / UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
Harbor - UCLA Med Ctr - Box 449
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs