Completed
Safety and Efficacy of MK-639 and Stavudine in HIV-1 Seropositive, AZT-Experienced Patients
What is being tested
Indinavir sulfate
+ Stavudine
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
From 18 to 60 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on HIV-1 infected individuals who have previously received AZT treatment. The main goal is to evaluate the safety and effectiveness of a combination therapy involving two drugs: indinavir sulfate (MK-639) and stavudine (d4T). This research is important as it aims to find a new treatment option for HIV-1 patients who have already used AZT, potentially improving their care and addressing the challenges associated with managing this condition.
Principal SponsorMerck Sharp & Dohme LLC
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
540 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 18 to 60 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 SyndromeAIDS-Related ComplexHIV Infections
Criteria
6 inclusion criteria required to participate
CD4 count 50 - 500 cells/mm3
HIV infection
No active opportunistic infection or visceral Kaposi's sarcoma
Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor
Show More Criteria
8 exclusion criteria prevent from participating
Acute hepatitis
Antiretrovirals other than specified in protocol
Any nucleoside analogs within 2 weeks prior to study entry
Any prior protease inhibitor or d4T
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 1 location
CompletedOne Study Center