Completed

Saquinavir SGC in Combination Therapy for HIV-1 Infection

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What is being tested

Ritonavir

+ Nelfinavir mesylate

+ Saquinavir

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 16 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

NCT00002374
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

4 inclusion criteria required to participate
>= 3 months cumulative saquinavir HGC therapy.
Documented HIV infection.
Saquinavir HGC-experienced patients (>= 3 months cumulative therapy).
CD4 > 100 cells/mm3.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Pacific Oaks Med Ctr

Beverly Hills, United StatesOpen Pacific Oaks Med Ctr in Google Maps

Tower Infectious Diseases / Med Associates Inc

Los Angeles, United States

Community Research Initiative of South Florida

Coral Gables, United States

Ctr for Quality Care

Tampa, United States
Completed7 Study Centers