Completed

Adefovir Dipivoxil, Indinavir, Zidovudine, and Lamivudine for HIV Treatment

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What is being tested

Indinavir sulfate

+ Levocarnitine

+ Adefovir dipivoxil

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 16 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

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

This protocol is a stratified, randomized, open-label study of the safety and efficacy of adefovir dipivoxil with indinavir as quadruple therapy in combination with zidovudine and lamivudine, or as triple combination administered with either zidovudine or lamivudine or stavudine for 48 weeks in the treatment of HIV-infected patients with CD4 cell counts >= 100/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. Patients will be randomized to adefovir dipivoxil, indinavir, zidovudine, and lamivudine or adefovir dipivoxil, indinavir, and a nucleoside inhibitor (randomly assigned to receive zidovudine, lamivudine, or stavudine) or to indinavir, zidovudine, and lamivudine. Additionally, a daily dose of L-carnitine will be administered to all patients randomized to an arm containing adefovir dipivoxil.

NCT00002379
Principal SponsorGilead Sciences
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

100 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 DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

5 inclusion criteria required to participate
A minimum life expectancy of at least 1 year
An HIV-1 RNA plasma titer >= 5000 copies/ml within 14-21 days prior to the baseline visit
CD4 cell count >= 100 cells/mm3 within 14-21 days prior to the baseline visit
Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture)
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18 exclusion criteria prevent from participating
A new AIDS-defining event diagnosed within 1 month prior to baseline
Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit
Antiretroviral vaccine therapy within 60 days of baseline
Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements
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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

Phoenix Body Positive

Phoenix, United StatesOpen Phoenix Body Positive in Google Maps

AIDS Healthcare Foundation Labs

Los Angeles, United States

Davies Med Ctr

San Francisco, United States

Blick Med Associates

Greenwich, United States
Completed15 Study Centers