Search / Trial NCT00000891

Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315

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

Apply for Trial

Trial Information

Current as of March 02, 2024

Completed

Keywords

Drug Therapy, Combination Hypersensitivity, Delayed Follow Up Studies Anti Hiv Agents Viral Load

Description

Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART. Patients continue their current ACTG 315 regimen of zidovudine plus lamivudine plus ritonavir in an open-label fashion while undergoing 6 weeks of extensive evaluations. Treatment decisions are based on baseline viral load (mean of 2 viral load measurements taken during 6...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Protocol Chair-approved antiretroviral medications or research study treatment for an HIV complication.
  • Treatment, maintenance, or chemoprophylaxis with approved medications for opportunistic infections.
  • Antibiotics.
  • 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, testosterone, or any other medication not explicitly excluded.
  • Alternative therapies such as vitamins, acupuncture, and visualization techniques.
  • Patients must have:
  • HIV-positive status.
  • Completion of 48 weeks of study treatment in ACTG 315 and maintenance in this regimen (on-study) until enrollment in this study.
  • Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions and symptoms are excluded:
  • Documented or suspected pancreatitis or hepatitis within 2 weeks prior to study entry.
  • Concurrent Medication:
  • Excluded:
  • Immunomodulators that affect immunologic or virologic indices (e.g., systemic corticosteroids, thalidomide, cytokines).
  • Ketoconazole, rifampin, and rifabutin.
  • Amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, dihydroergotamine, encainide, ergotamine, flecainide, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine, terfenadine, alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, zolpidem, phenytoin, phenobarbital, and carbamazepine.
  • [AS PER AMENDMENT 3/5/01:
  • Lovastatin and simvastatin.
  • Excluded for patients who are pregnant:
  • ddI or d4T.]
  • Avoided:
  • Herbal medications.
  • [2. AS PER AMENDMENT 4/10/00:
  • Use of ddI is contraindicated in patients who have serum amylase or lipase values over 1.5 times the ULN (Upper Limit of Normal), fasting triglycerides of 100 mg/dl or more, or a history of pancreatitis. Use ddI with extreme caution and only if clinically indicated in patients with known risk factors. Refer to package insert for more information.]
  • Concurrent Treatment:
  • Excluded:
  • Systemic cytotoxic chemotherapy.
  • Prior Medication:
  • Excluded:
  • Any antiretroviral medications other than the zidovudine, lamivudine, and ritonavir supplied in ACTG 315 or alternative antiretrovirals not approved by protocol chairs, 48 weeks prior to study entry.
  • Immunomodulatory therapies within 30 days prior to study entry.
  • Required:
  • Zidovudine (200 mg tid or 300 mg bid) plus lamivudine (150 mg bid) plus ritonavir (500 or 600 mg bid, or 300 mg tid) for 48 weeks in ACTG 315.
  • Active substance or alcohol abuse or dependence that would interfere with adherence to study requirements.

Attachments

readout_NCT00000891_2024-03-02.pdf

4.5 MB

NCT00000891_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

Chicago, Illinois, United States

Cleveland, Ohio, United States

Denver, Colorado, 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

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?

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?

Discussion 0