Completed
FORTOVASE and NRTIs Combination for HIV-1 Infected Individuals
What is being tested
Saquinavir
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
From 16 to 64 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Summary
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
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
80 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.From 16 to 64 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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
6 inclusion criteria required to participate
Agree to use effective methods of birth control during the study
Are 16 - 64 years old (need consent if under 18)
Are HIV-positive
Have a CD4 count of 100 cells/mm3 or more
Show More Criteria
8 exclusion criteria prevent from participating
Abuse alcohol or drugs
Are pregnant or breast-feeding
Are unable to complete the study for any reason
Have a history of weight loss, muscle pain, and loss of appetite
Show More Criteria
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 22 locations
Dean Martin
Phoenix, United StatesWilbert Jordan
Paramount, United StatesWhitman Walker Clinic
Washington D.C., United StatesCompleted22 Study Centers