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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038220
Recruitment Status : Completed
First Posted : May 30, 2002
Last Update Posted : July 27, 2006
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lopinavir/ritonavir Drug: Efavirenz Drug: Lamivudine Drug: Tenofovir DF Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1
Study Start Date : July 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038220

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United States, New York
Aaron Diamond AIDS Research Center - Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
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Study Director: Scott Brun, M.D. Head, Antiviral Global Project Team
Layout table for additonal information Identifier: NCT00038220    
Obsolete Identifiers: NCT00006189
Other Study ID Numbers: M00-154
First Posted: May 30, 2002    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: July 2006
Keywords provided by Abbott:
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers