Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002229 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

Official Title ^ICMJE

A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men

Brief Summary

The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.

Detailed Description

Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Pharmacokinetics Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Saquinavir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Have an HIV count of 5,000 copies/ml or more.
Have a CD4 count of 100 cells/mm3 or more.
Meet specific requirements if you have ever taken NRTIs.
Are 16 - 64 years old (need consent if under 18).
Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
Have taken all the available NRTIs.
Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
Have a history of weight loss, muscle pain, and loss of appetite.
Have taken certain medications, including anti-HIV drugs other than those required by this study.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.
Are unable to complete the study for any reason.

Gender

Both

Ages

16 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00002229

Responsible Party

Study ID Numbers ^ICMJE

229Q, NR15750

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	S Palleja
Study Chair:	C Karol

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

December 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP