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

Abbott

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: Efavirenz

Drug: Lopinavir/ritonavir

Drug: Lamivudine

Drug: Tenofovir DF

Study type

Interventional

Funder types

Industry

Identifiers

M00-154

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.