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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lopinavir/ritonavir

Efavirenz

Lamivudine

Tenofovir DF

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Aaron Diamond AIDS Research Center - Rockefeller University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00038220

First Posted

May 29, 2002

Last Updated

July 26, 2006

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00038220

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2006

Overall Recruitment Status

Completed

Study Start Date

July 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lopinavir/ritonavir

Intervention Type

Drug

Intervention Name(s)

Efavirenz

Intervention Type

Drug

Intervention Name(s)

Lamivudine

Intervention Type

Drug

Intervention Name(s)

Tenofovir DF

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Brun, M.D.

Organizational Affiliation

Head, Antiviral Global Project Team

Official's Role

Study Director

Facility Information:

Facility Name

Aaron Diamond AIDS Research Center - Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial