Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

This study is ongoing, but not recruiting participants.

Sponsored by:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002451

Purpose

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

Condition	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Ritonavir Drug: Lamivudine Drug: Stavudine	Phase II

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Lamivudine Indinavir Indinavir Sulfate Stavudine Ritonavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study
Official Title:	A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

Detailed Description:

Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Are at least 18 years old.
Have a viral load of 5,000 copies/ml or greater.
Have a CD4 count of at least 50 cells/mm3.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have taken any antiretroviral (anti-HIV) agent.
Are pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002451

Locations

United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
United States, New York
Albany Med College
Albany, New York, United States, 12208
SUNY at Stony Brook / Division of Infectious Diseases
Stony Brook, New York, United States, 11794

Sponsors and Collaborators

Merck

More Information

Study ID Numbers:	246U, 104-00
Study First Received:	January 17, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002451
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
CD4 Lymphocyte Count
Ritonavir

Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Indinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009