Search / Trial NCT00000885

Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Hiv 1 Drug Therapy, Combination Zidovudine Hiv Protease Inhibitors Lamivudine Indinavir Rna, Viral Treatment Failure Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

Description

This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-te...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients with a CD4 cell count of 200 cells/mm3 or less.
  • Allowed:
  • Treatment, maintenance, or chemoprophylaxis, including topical and/or oral antifungal agents unless otherwise excluded by the protocol.
  • All antibiotics as clinically indicated, unless otherwise excluded in the protocol.
  • Systemic corticosteroid use for 21 days or less for acute problems as medically indicated. Chronic corticosteroid use is not permitted, unless it is within physiologic replacement levels. Study team must be contacted in these instances.
  • rEPO and G-CSF as medically indicated.
  • Regularly prescribed medications such as [AS PER AMENDMENT 06/29/98: alternative, FDA-approved antiretrovirals not supplied by the study] [AS PER AMENDMENT 12/27/01: or unapproved antiretrovirals available by expanded access (when permanently discontinued from randomized study treatment)], antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate, testosterone, or any other medications not otherwise excluded by the protocol, as medically indicated.
  • [AS PER AMENDMENT 12/27/01: Supplemental and] alternative therapies such as vitamins, acupuncture, and visualization techniques.
  • Recommended as an alternative agent for chemoprophylaxis against Mycobacterium avium complex for patients randomized to EFV in Group B or D:
  • clarithromycin or azithromycin.
  • Patients must have:
  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by either a Western Blot, HIV culture, HIV antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry.
  • Non-ACTG patients:
  • Documented CD4 cell count of 200 cells/mm3 or less at the time of initiation of ZDV (or d4T) plus 3TC plus IDV.
  • Signed, informed consent from a parent or legal guardian for patients under 18 years of age.
  • Prior Medication:
  • Required:
  • Non-ACTG 320 patients:
  • At least 3 months prior therapy with ZDV (or d4T) plus 3TC plus IDV and continued receipt of ZDV (or d4T) plus 3TC plus IDV until enrollment. IDV and 3TC must have been initiated concurrently.
  • ACTG patients:
  • Randomization to the ZDV (or d4T) plus 3TC plus IDV combination arm or receipt of open-label prior to unblinding and maintenance of that treatment as participation in ACTG 320.
  • Group D:
  • Prior NNRTI-exposure.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions and symptoms are excluded:
  • Unexplained temperature above 38.5 C for any 7 days or chronic diarrhea, defined as more than 3 liquid stools per day persisting for 15 days, within 30 days prior to study treatment.
  • AIDS-related malignancy, other than minimal Kaposi's sarcoma that requires systemic chemotherapy. Minimal Kaposi's sarcoma is defined as 5 or fewer cutaneous lesions and no visceral disease or tumor-associated edema that does not require systemic therapy.
  • Documented or suspected acute hepatitis within 30 days prior to study entry, irrespective of laboratory values.
  • Concurrent Medication:
  • Excluded:
  • All antiretroviral therapies other than study [AS PER AMENDMENT 06/16/99: provided] medications, [AS PER AMENDMENT 06/16/99: unless approved by the protocol chairs] [AS PER AMENDMENT 12/27/01: while on original randomized treatment.]
  • Rifabutin and rifampin.
  • Investigational agents without specific approval from the protocol chair.
  • Systemic cytotoxic chemotherapy.
  • Oral ketoconazole and itraconazole. NOTE: Itraconazole may be permitted for Group B and Group D patients if fluconazole is not an option.
  • Terfenadine, astemizole, cisapride, triazolam, midazolam, amiodarone, quinine, ergot derivatives, isotretinoin, [AS PER AMENDMENT 12/27/01: pimozide, St.John's Wort, and milk thistle.]
  • [AS PER AMENDMENT 12/27/01: Concomitant use of lovastatin or simvastatin is not recommended because of potential drug interactions. Pravastatin or atorvastatin may be used after consultation with the Study Team.]
  • To be avoided:
  • Herbal medications.
  • Prior Medication:
  • Excluded:
  • Any prior protease inhibitor therapy other than indinavir.
  • Interferons, interleukins, or HIV vaccines within 30 days prior to study entry.
  • Any experimental therapy within 30 days prior to study entry.
  • Rifampin, rifabutin, ketoconazole, or itraconazole within 14 days of study entry.
  • Non-ACTG patients:
  • Acute therapy for an infection or other medical illness within 14 days prior to study therapy.
  • NNRTI therapy prior to study entry (with the exception of Group D).
  • Recombinant erythropoietin (rEPO), granulocyte colony-stimulating factor (G-CSF, filgrastim), or granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) within 30 days prior to study entry.
  • Caution should be taken in the consumption of alcoholic beverages with study medications.

Attachments

readout_NCT00000885_2023-12-10.pdf

4.5 MB

NCT00000885_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

Saint Louis, Missouri, 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

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, 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

Boston, Massachusetts, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Galveston, Texas, United States

San Juan, , Puerto Rico

Boston, Massachusetts, United States

Charlotte, North Carolina, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Knoxville, Tennessee, United States

Iowa City, Iowa, United States

Houston, Texas, United States

Nashville, Tennessee, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, 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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