Completed

Amprenavir's Impact on Carbohydrate and Lipid Metabolism in HIV-1 Infected Patients

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What is being tested

Abacavir sulfate

+ Amprenavir

+ Lamivudine

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 1999
See protocol details

Summary

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

Study start date: April 1, 1999

Actual date on which the first participant was enrolled.

This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC.

NCT00002245
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.

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 DiseasesHyperinsulinismImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGlucose Metabolism DisordersInsulin ResistanceHIV Infections

Criteria

6 inclusion criteria required to participate
Agree to use effective methods of birth control during the study

Are HIV-positive

Are at least 18 years old

Have a CD4 count greater than or equal to 200 cells/mm3 within 30 days prior to study entry

Show More Criteria

16 exclusion criteria prevent from participating
Abuse alcohol or drugs

Are allergic to any of the study drugs

Are pregnant

Have a history of diabetes

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

LAC / USC Med Ctr / Infectious Diseases

Los Angeles, United StatesOpen LAC / USC Med Ctr / Infectious Diseases in Google Maps
CompletedOne Study Center