Completed

Comparison of Indinavir Sulfate Dosages in Combination with Zidovudine and 3TC for HIV Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Indinavir sulfate

+ Lamivudine

+ Stavudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 16 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to 1 of 2 arms: Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).

NCT00002208
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

400 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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

4 inclusion criteria required to participate
CD4 count greater than 100 cells/mm3
HIV-1 seropositive status
Consent from parent or guardian if less than 18 years of age
Viral RNA above 10,000 copies/mL
2 exclusion criteria prevent from participating
Prior therapy with protease inhibitors
Prior therapy with 3TC

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 15 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

LAC/USC Med Ctr

Los Angeles, United States

Kaiser Med Ctr

San Francisco, United States

Wilmington Hosp / Med Ctr of Delaware

Wilmington, United States
Completed15 Study Centers