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A Study to Compare Two Anti-HIV Drug Combinations

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ritonavir

Efavirenz

Saquinavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz

Eligibility Criteria

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

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3. Are at least 18. Are able to complete the study. Exclusion Criteria Patients will not be eligible for this study if they: Have taken any anti-HIV medications for more than 2 weeks. Are pregnant or breast-feeding.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002447

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00002447

Brief Title

A Study to Compare Two Anti-HIV Drug Combinations

Official Title

An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2001

Overall Recruitment Status

Completed

Study Start Date

October 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to compare 2 anti-HIV drug combinations.

Detailed Description

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

146 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ritonavir

Intervention Type

Drug

Intervention Name(s)

Efavirenz

Intervention Type

Drug

Intervention Name(s)

Saquinavir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: