Skip to main content
OpenTrials
Completed

NCT Number: NCT00038220

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aaron Diamond AIDS Research Center - Rockefeller University

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lopinavir/ritonavir

Drug

Efavirenz

Drug

Lamivudine

Drug

Tenofovir DF

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2000
First posted
May 30, 2002
Registry last updated
Jul 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.