Working… Menu

A Study of Two Anti-HIV Drug Combinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002203
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:

The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.

Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lamivudine/Zidovudine Drug: Lamivudine Drug: Zidovudine Not Applicable

Detailed Description:

It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.

Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

  • HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
  • CD4+ cell count of at least 300 cells/mm3.
  • HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
  • CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
  • Compliance with dosing schedule and protocol evaluations.

Prior Medication:


  • 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.


  • Inhaled corticosteroids for the treatment of asthma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
  • Enrollment in other investigational protocols.

Concurrent Medication:


  • Cytotoxic chemotherapeutic agents.
  • Nonnucleoside reverse transcriptase inhibitors.
  • Other investigational agents.

Concurrent Treatment:


Radiation therapy.

Prior Medication:


  • Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
  • HIV immunotherapeutic vaccine within 3 months of study entry.

Prior Treatment:


Radiation therapy within 4 weeks of study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002203

Layout table for location information
United States, California
Pacific Oaks Med Ctr
Beverly Hills, California, United States, 90211
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States, 90048
United States, North Carolina
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States, 27599
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28232
United States, Virginia
Infectious Diseases Physicians Inc
Annandale, Virginia, United States, 22003
United States, Wisconsin
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States, 53792
Puerto Rico
San Juan AIDS Program
Santurce, Puerto Rico, 00907
Sponsors and Collaborators
Glaxo Wellcome
Layout table for additonal information Identifier: NCT00002203    
Other Study ID Numbers: 280A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 1998
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
CD4 Lymphocyte Count
CD4-CD8 Ratio
Patient Compliance
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents