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A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients



A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Abbott Laboratories ,
Synopsis: The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - CD4 cell count greater than 100 cells/microliter. - HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay. - No acute illness. - Consent of parent or guardian if less than legal age. - No prior enrollment in this study. - All entry criteria for this study met within 15 days prior to enrollment. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Any condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study. Concurrent Medication: Excluded: - Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen. - Any of the following medications with ritonavir: - midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine. - Any of the following medications with indinavir: - terfenadine, astemizole, cisapride, triazolam, midazolam. No requirement for rifampin or ketoconazole. - Any concurrent treatment with other protease inhibitors. - Other concurrent medication (including over-the-counter medicine or alcohol) without the knowledge and permission of the primary investigator. Patients with the following prior conditions are excluded: - History of significant drug hypersensitivity. - Psychiatric illness that precludes compliance with the protocol. - Receipt of investigational drug within 30 days prior to administration of study drug. - History of acute or chronic pancreatitis. - Anticipation of poor patient compliance with protocol. Prior Medication: Excluded: Prior treatment with ritonavir. Risk Behavior: Excluded: History of active substance abuse (i.e., recreational drugs or alcohol). Included: Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.
Total Enrollment: 

Location and Contact Information:

Stephen Hauptman
Philadelphia,  Pennsylvania,  19107
United States
 

Tower Infectious Diseases
Los Angeles,  California,  90048
United States
 

Goodgame Med Ctr / Central Florida Research Initiati
Maitland,  Florida,  32751
United States
 

AIDS Healthcare Foundation
Los Angeles,  California,  90027
United States
 

Urgent Care Ctr / North Broward Hosp District
Ft. Lauderdale,  Florida,  33316
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 


Additional Information:
Study ID Numbers:
  245E;  M98-823
Study Start Date: 
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002223

Other Hiv Infections Studies:
1. Treatment of Acute HIV Infection to Preserve Immune Function

2. The Safety and Effectiveness of Different Doses of Vitamin C in HIV-Infected Patients

3. An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection

4. A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC

5. A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients

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