A Study to Compare Two Anti-HIV Drug Combinations

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002447

Enrollment

146

Registered

2001-08-31

Start date

1999-10-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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.

Interventions

DRUGRitonavir

DRUGEfavirenz

DRUGSaquinavir

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

Canada, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026