Completed

Combination Antiretroviral Therapy with 1592U89, 141W94, and DMP 266 for HIV-1 Treatment

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

Abacavir sulfate

+ Amprenavir

+ Efavirenz

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

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

This is a multicenter, open-label study. A total of 80 patients are treated on this study and include: At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs). All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows: 1592U89 plus 141W94 plus DMP 266.

NCT00002213
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

80 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 13 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

8 inclusion criteria required to participate
Detoxification treatment including opiate agonists (methadone, buprenorphine, etc.): Patients currently receiving this treatment should be enrolled only if stable on this therapy
Drugs that may interact with CYP3A4, that should be used with caution including (but not limited to): alprazolam, carbamazepine, codeine, cimetadine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, simvastatin, and warfarin
HIV-1 RNA greater than 500 copies/ml when measured on 1 occasion within 14 days of study drug administration
HIV-1 infection (all CDC clinical categories allowed)
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19 exclusion criteria prevent from participating
Active AIDS-defining opportunistic infection or disease that is likely to preclude the patient from study participation
Active alcohol or illicit drug use that is likely to interfere with dosing schedule compliance and protocol evaluations
Anti-oxidants
Anticipated need for radiation therapy (with the exception of local treatment for Kaposi's sarcoma)
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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 9 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

Kraus Med Partners

Los Angeles, United States

Northwestern Univ Med School AIDS Treatment Unit

Chicago, United States

Niaid / Nih

Bethesda, United States
Completed9 Study Centers