A Study of Efavirenz in Combination With Stavudine and Didanosine

NCT00002225 | Completed Phase 2

• 2 other identifiers: 281DDMP 266-044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Stavudine; Reverse Transcriptase Inhibitors; efavirenz

Interventions

Efavirenz DRUG

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
• A life expectancy of at least 12 months.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Current bilateral peripheral neuropathy greater than or equal to Grade 2.
• Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
• Any clinically significant disease (other than HIV infection) or clinically significant findings during screening of medical history or physical examination.
• Any malignancy that requires systemic therapy.
• Proven or suspected acute hepatitis due to any cause.
• Recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4 days within 3 months prior to dosing.
• Active AIDS-defining opportunistic infection or disease.
• Concurrent Medication:
• Excluded:
• Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine.
• Patients with the following prior conditions are excluded:
• History of acute or chronic pancreatitis.
• Life expectancy less than 12 months.

Sponsors & Collaborators

• Dupont Merck: lead

Study Sites (5)

The Whitman Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

North Shore AIDS Hosp / Division of Infectious Disease

Manhassett, New York, 11030, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Carolinas Research Associates

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz; Stavudine; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-11

Locations

US (5)