Completed

141W94 and Indinavir Combination with NRTIs for HIV-1 Treatment

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What is being tested

Indinavir sulfate

+ Amprenavir

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on comparing the safety and antiviral effectiveness of a drug called 141W94 to another drug named indinavir. Both of these drugs are used in combination with nucleoside reverse transcriptase inhibitors (NRTIs), which are medications that help control HIV infection. The study involves individuals who have previously used NRTIs but have not used protease inhibitors, a type of HIV medication. The main goal is to find out if 141W94 can be as effective and safe as indinavir when used with NRTIs for a period of 48 weeks. This research is important as it could potentially lead to new treatment options for HIV-1-infected patients. During this study, participants will receive either 141W94 or indinavir along with their NRTIs. The effects of these drugs will be monitored over 48 weeks to evaluate their safety and effectiveness. The study also looks at how other drugs might affect the way the body processes 141W94. The results will be measured by looking at changes in HIV levels in the blood and any side effects that may occur. This will help researchers understand the potential benefits and risks of using 141W94 in combination with NRTIs.

NCT00002202
Principal SponsorGlaxo Wellcome
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

460 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 18 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
Documented HIV infection

HIV RNA >= 400 copies/ml within 14 days prior to randomized study drug administration

No active AIDS-defining opportunistic infection or disease

Signed, informed consent from parent or legal guardian of patients less than 18 years of age

15 exclusion criteria prevent from participating
Clinically relevant pancreatitis or hepatitis within the last 6 months

Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication

Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma)

Cytotoxic chemotherapeutic agents within 30 days of study drug administration (except local treatment for Kaposi's sarcoma)

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 24 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

AIDS Healthcare Foundation

Los Angeles, United States

Saint Francis Mem Hosp

San Francisco, United States

ViRx Inc

San Francisco, United States
Completed24 Study Centers