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Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002241
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 2001
History of Changes
  Purpose

The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.


Condition Intervention Phase
HIV Infections
 Drug: Indinavir sulfate
Drug: Ritonavir
Drug: Lamivudine
Drug: Stavudine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 80
Detailed Description:

Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.

  Eligibility

Ages Eligible for Study:   16 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.
  • Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
  • Are age 16 or older (consent of a parent or guardian required if under 18).
  • Agree to practice abstinence or use barrier methods of birth control (such as condoms).
  • Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
  • Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
  • Have changed their medications in the last 2 weeks.
  • Are allergic to IDV, RTV, d4T, or 3TC.
  • Have used certain medications (see the technical summary for more detail).
  • Are pregnant or breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002241

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Apogee Med Group
San Diego, California, United States, 92101
Univ of California at San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
HIV Institute / Davies Med Ctr
San Francisco, California, United States, 94114
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
CRI New England
Brookline, Massachusetts, United States, 02146
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Montefiore Med Ctr
Bronx, New York, United States, 10467
SUNY Health Sciences Ctr
Brooklyn, New York, United States, 11203
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, United States, 10019
Chelsea Village Med Ctr
New York, New York, United States, 10014
Liberty Med Group
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, Pennsylvania
Mark Watkins
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Univ of Texas / Thomas Street Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002241     History of Changes
Other Study ID Numbers: 246T, 094-00, CRX463
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Ritonavir
Lamivudine
 Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Indinavir
Ritonavir
 Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013