Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients

NCT00038220 | Completed Phase 2

• 1 other identifier: M00-154
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.

Interventions

Lopinavir/ritonavir DRUG

Efavirenz DRUG

Lamivudine DRUG

Tenofovir DF DRUG

Eligibility Criteria

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

You may qualify if:

• Have HIV Infection.
• Age 18 to 65 years old.
• Show no signs of recent illness other than HIV infection.
• Agree to use a barrier method of birth control during the study and for 30 days after study.

You may not qualify if:

• Are unable to follow study requirements (in the opinion of the investigator).
• Are pregnant or breast-feeding.
• Are unable to take medications by mouth.
• Have chronic nausea or vomiting.
• Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
• Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening.
• Are taking any medications that are not allowed with ABT-378/r and efavirenz.
• Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor.
• Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor.
• Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements.
• Have a history of kidney or bone disease.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Aaron Diamond AIDS Research Center - Rockefeller University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir; efavirenz; Lamivudine; Tenofovir

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)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Scott Brun, M.D.

  Head, Antiviral Global Project Team

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2002
• First Posted: May 30, 2002
• Study Start: July 1, 2000
• Last Updated: July 27, 2006

Record last verified: 2006-07

Locations

US (1)