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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038220
First received: May 29, 2002
Last updated: July 26, 2006
Last verified: July 2006

May 29, 2002
July 26, 2006
July 2000
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Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.
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Complete list of historical versions of study NCT00038220 on ClinicalTrials.gov Archive Site
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Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
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

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/ritonavir
  • Drug: Efavirenz
  • Drug: Lamivudine
  • Drug: Tenofovir DF
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038220
M00-154
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Abbott
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Study Director: Scott Brun, M.D. Head, Antiviral Global Project Team
Abbott
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP