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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038220
• Other study ID #: M00-154
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2002
• Last updated: July 26, 2006
• Start date: July 2000

Study information

• Verified date: July 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00006189

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lopinavir/ritonavir

• Efavirenz

• Lamivudine

• Tenofovir DF

Locations

Country	Name	City	State
United States	Aaron Diamond AIDS Research Center - Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.