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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: May 29, 2002
Last updated: July 26, 2006
Last verified: July 2006
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 Intervention Phase
HIV Infections
Drug: Lopinavir/ritonavir
Drug: Efavirenz
Drug: Lamivudine
Drug: Tenofovir DF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Abbott:

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

Estimated Enrollment: 40
Study Start Date: July 2000

Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00038220

United States, New York
Aaron Diamond AIDS Research Center - Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Study Director: Scott Brun, M.D. Head, Antiviral Global Project Team
  More Information Identifier: NCT00038220     History of Changes
Obsolete Identifiers: NCT00006189
Other Study ID Numbers: M00-154
Study First Received: May 29, 2002
Last Updated: July 26, 2006

Keywords provided by Abbott:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers processed this record on April 26, 2017