search
Back to results

A Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis

Primary Purpose

Cytomegalovirus Retinitis, 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 Cytomegalovirus Retinitis focused on measuring AIDS-Related Opportunistic Infections, Placebos, Antiviral Agents, Cytomegalovirus Retinitis, Treatment Outcome, Nelfinavir

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV infection. Newly diagnosed or first progression of CMV retinitis. Exclusion Criteria Prior Medication: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitor other than saquinavir.

Sites / Locations

  • Univ of Southern California / LA County USC Med Cntr
  • Univ of California / UCI Med Ctr
  • Univ of California / San Diego Treatment Ctr
  • Harbor UCLA Med Ctr
  • George Washington Univ
  • Northwestern Univ / SOCA
  • Univ of Texas Med Branch
  • Baylor Univ

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
NCT00002169
Brief Title
A Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis
Official Title
A Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Cytomegalovirus (CMV) Retinitis in AIDS Patients Who Are Receiving Standard Induction and Maintenance Therapy for This Infection
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
The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are already being treated for cytomegalovirus (CMV) retinitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Placebos, Antiviral Agents, Cytomegalovirus Retinitis, Treatment Outcome, Nelfinavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

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 infection. Newly diagnosed or first progression of CMV retinitis. Exclusion Criteria Prior Medication: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitor other than saquinavir.
Facility Information:
Facility Name
Univ of Southern California / LA County USC Med Cntr
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
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
George Washington Univ
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Northwestern Univ / SOCA
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis

We'll reach out to this number within 24 hrs