Search / Trial NCT00000892

A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Hiv 1 Drug Therapy, Combination Hiv Protease Inhibitors Ritonavir Indinavir Rna, Viral Saquinavir Delavirdine Nelfinavir Adenine Anti Hiv Agents Viral Load

Description

While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transc...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4 cell count of equal or less than 200 cells/mm3.
  • Allowed:
  • Topical and oral antifungal agents except ketoconazole and itraconazole.
  • Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic infections.
  • Antibiotics.
  • Systemic corticosteroids for 21 days or less for acute problems.
  • Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
  • Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (not as a sole form of birth control), megestrol acetate, or testosterone.
  • Alternative therapies, such as vitamins, acupuncture, and visualization techniques.
  • [AS PER AMENDMENT 3/30/98: Calcium channel blockers may be used only with caution.]
  • Patients must have:
  • HIV-1 infection documented by a licensed ELISA and confirmed by Western blot, HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test other than ELISA.
  • 2,000 to 200,000 HIV-1 RNA copies/ml as measured by any Roche-certified laboratory [AS
  • PER AMENDMENT 3/30/98:
  • using the Roche Amplicor HIV-1 Monitor] within 30 days of study entry.
  • Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
  • Prior Medication: Required:
  • More than 6 months cumulative indinavir therapy.
  • Stable indinavir-containing antiretroviral regimen for at least 4 weeks [2 weeks AS PER AMENDMENT 3/30/98] prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Any active infection requiring acute treatment within 30 days [21 days AS PER AMENDMENT 3/30/98] prior to study entry.
  • Unexplained temperature greater than 38.5 degrees for any 7 consecutive days within 30 days prior to study entry.
  • Malignancy, including Kaposi's sarcoma, that requires systemic chemotherapy.
  • Concurrent Medication:
  • Excluded:
  • Non-protocol-specified immunomodulatory and/or antiretroviral agents.
  • Systemic cytotoxic chemotherapy.
  • Ketoconazole, itraconazole, rifampin, rifabutin, alprazolam, amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, encainide, estazolam, flecainide, flurazepam, isotretinoin, meperidine, midazolam, piroxicam, propafenone, propoxyphene, quinidine, terfenadine, triazolam, zolpidem, phenytoin, phenobarbital, carbamazepine, and ergot alkaloids and [ AS PER AMENDMENT 3/30/98: dexamethasone, ergot derivatives, and pimozide].
  • Avoided:
  • Herbal medications.
  • Prior Medication:
  • Excluded:
  • At least 2 weeks or more total ritonavir and/or saquinavir (hard gelatin capsule).
  • NNRTIs (nevirapine, delavirdine, DMP-266, etc.), saquinavir (soft gelatin capsule), nelfinavir, 141W94VX-478, and adefovir dipivoxil.
  • Immunomodulator [systemic immunomodulator AS PER AMENDMENT 3/30/98] or investigational drug therapy within 30 days prior to entry.
  • Active immunization within 30 days [21 days AS PER AMENDMENT 3/30/98] prior to entry.

Attachments

readout_NCT00000892_2024-07-23.pdf

4.5 MB

NCT00000892_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

San Francisco, California, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Torrance, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Buffalo, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Los Angeles, California, United States

Minneapolis, Minnesota, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Knoxville, Tennessee, United States

New York, New York, United States

Menlo Park, California, United States

New York, New York, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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