Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment

NCT00005017 | Unknown Phase 4

• 2 other identifiers: 264NESS40001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment: 1) lamivudine (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir (APV)/ritonavir (RTV).

Conditions

HIV Infections

Keywords

HIV-1; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; Ritonavir; Lamivudine; VX 478; Reverse Transcriptase Inhibitors; Anti-HIV Agents; abacavir; efavirenz

Interventions

Ritonavir DRUG

Abacavir sulfate DRUG

Amprenavir DRUG

Efavirenz DRUG

Lamivudine DRUG

Stavudine DRUG

Eligibility Criteria

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

You may qualify if:

• Patients may be eligible for this trial if they:
• Are HIV-positive.
• Are at least 18 years old.
• Have a viral load of at least 5,000 copies/ml.
• Have a CD4 count of at least 50 cells/mm3.
• Agree to practice effective methods of birth control while on the study, if a woman.
• Patients are not eligible for this trial if they:
• Are pregnant or breast-feeding. Have ever taken anti-HIV drugs. (Less than 2 weeks of prior anti-HIV treatment is allowed.) Have a history of AIDS-defining opportunistic illness (except for Kaposi's sarcoma involving skin) within 45 days of the screening visit. Treatment for the illness must have been completed at least 30 days prior to screening.
• Are enrolled in another study where the medication may interfere with the control of viral load in this study.
• Have a serious medical condition such as diabetes or heart problems that would make it unsafe to be on this study.
• Have a history of a severe nerve disease of the type that may cause muscle weakness.
• Have had pancreatitis (inflamed pancreas) or hepatitis within 6 months of starting the study.
• Have had radiation treatment or chemotherapy within 4 weeks prior to study entry, or think those treatments may be needed during the study period. Local treatment for Kaposi's sarcoma is allowed.
• Have used certain medications, including vaccines, that interfere with the immune system within 4 weeks prior to study entry.
• Have taken an HIV vaccine within 3 months prior to entry. Are taking St. John's wort. Have a history of being allergic to any of the study drugs.

Sponsors & Collaborators

• Glaxo Wellcome: lead

Study Sites (1)

Jaime Hernandez

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir; abacavir; amprenavir; efavirenz; Lamivudine; Stavudine

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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2000
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2001-06

Locations

US (1)