Search / Trial NCT00000919

A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection

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

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Trial Information

Current as of April 16, 2024

Completed

Keywords

Hiv Protease Inhibitors Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

Description

Highly active antiretroviral therapy, though effective in the suppression of HIV proliferation, is often complicated by difficulties with adherence and drug toxicity. Various combinations of highly active antiretroviral therapy exist; all have proved efficacious in related trials. The question addressed in this trial is which combination of antiretroviral "cocktails" provides the single greatest advantage in preventing the spread of HIV in the body. In effect, which therapy provides the greatest benefit with the fewest complications. Step 1: Patients are randomized to 1 of 6 arms: Arm A: ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • [Required: AS PER AMENDMENT 7/5/00:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia if CD4+ cell count is less than or equal to 200 cells/mm3.]
  • [Suggested as an alternative agent for chemoprophylaxis against Mycobacterium avium complex:
  • Azithromycin.]
  • [Allowed: AS PER AMENDMENT 7/5/00:
  • Topical and oral antifungal agents. Oral itraconazole may be administered concurrently with IDV if the dose of IDV is reduced to 600 mg every 8 hours.
  • Treatment, maintenance, or chemoprophylaxis for opportunistic infections, as clinically indicated unless otherwise prohibited by the protocol.
  • All antibiotics, as clinically indicated unless otherwise prohibited by the protocol.
  • Systemic corticosteroid use for 21 days or less for acute problems, as medically indicated.
  • Recombinant erythropoietin (rEPO, epoetin alfa, Epogen, epoetin beta, Marogen), granulocyte colony-stimulating factor (G-CSF, filgrastim, Neupogen), and granulocyte-macrophage colony-stimulating factor (GM-CSF, Regramostim).
  • Regularly prescribed medications, such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate (Megace), testosterone, or any other medications, as medically indicated unless otherwise prohibited by the protocol. NOTE: Due to the possibility that study medications may alter the effectiveness of oral contraceptives or depoprogesterone, these agents must not be used as the sole form of birth control, because the role of some study medications on the effectiveness of these methods has not yet been established.
  • Alternative therapies, such as vitamins.
  • Medications requiring low gastric pH if not administered at the same time as buffered ddI. Patients taking these agents should do so at least 2 hours before ddI.]
  • Vaccinations, if administered at least 2 weeks prior to an HIV RNA viral load evaluation.
  • [Allowed with caution: AS PER AMENDMENT 7/5/00:
  • Oral ketoconazole with IDV.
  • Medications that interact with PIs as substrates, inhibitors, or inducers, including, but not limited to:
  • allopurinol, alprazolam, amitriptyline, atorvastatin, bupropion, carbamazepine, cerivastatin, chlorpheniramine, chlorpromazine, chlorzoxazone, cimetidine, clarithromycin, clofibrate, clorazepate, clozapine, codeine, dapsone, desipramine, diazepam, diltiazem, disopyramide, encainide, erythromycin, estazolam, estrogens and progesterones, fluoxetine, flurazepam, fluvastatin, glucocorticoids, hypericum perforatum (St. John's wort), imipramine, isoniazid, itraconazole, ketoconazole, labetalol, lamotrigine, lidocaine, lovastatin, mexiletine, morphine, naloxone, nefazodone, nifedipine, nortriptyline, opioids, oxazepam, pentazocine, phenobarbital, phenytoin, promethazine, propofol, propranolol and other beta blockers, sildenafil, simvastatin, temazepam, T3 (thyroid hormone), warfarin, valproic acid, and zolpidem.
  • Drugs with high protein-binding properties, nephrotoxic drugs, and opiate agonists (e.g., methadone or buprenorphine).]
  • NOTE:
  • Refer to package insert for potential drug interactions with IDV, RTV, NFV, or APV that may require therapeutic drug monitoring and/or adjustment of concomitant medications.]
  • [Allowed with extreme caution:
  • AS PER AMENDMENT 7/5/00:
  • ddI, as clinically indicated in patients with known risk factors, including, but not limited to, alcohol abuse, morbid obesity, hypertriglyceridemia, cholelithiasis, endoscopic retrograde cholangiopancreatography, use of medications known to cause pancreatitis (e.g., pentamidine) and use of medications known or thought to increase exposure to ddI (e.g., HU, allopurinol).]
  • Concurrent Treatment:
  • [Allowed:
  • AS PER AMENDMENT 7/5/00:
  • Acupuncture and visualization techniques.]
  • Patients must have:
  • HIV infection, as documented by any licensed ELISA test kit and confirmed by either 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.
  • Plasma HIV-1 RNA of 500 copies/ml or more, confirmed by the Roche Amplicor assay only and performed within 60 days [AS PER AMENDMENT 5/5/99:
  • 70 days] of study entry by any certified laboratory.
  • Inclusion laboratory parameters, documented within 14 days prior to study entry (see lab values).
  • [AS PER AMENDMENT 9/9/99:
  • Co-enrollment on ACTG A5005s (Metabolism Substudy) is required for patients enrolling under Version 3.0 of ACTG 384.]
  • Risk Behavior:
  • [Allowed with caution:
  • AS PER AMENDMENT 7/5/00:
  • Alcoholic beverages.]
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following condition are excluded:
  • AIDS-related malignancy other than minimal Kaposi's sarcoma.
  • Concurrent Medication:
  • [Excluded:
  • AS PER AMENDMENT 7/5/00:
  • Chronic systemic corticosteroids.
  • For Steps 1 and 2, all antiretroviral therapies other than study medications. For step 3, contact the team to discuss potential addition or substitution with off-study antiretroviral medications.
  • Investigational drugs without specific approval from the study chairs.
  • Neurotoxic and pancreatotoxic drugs.
  • Systemic cytotoxic chemotherapy.
  • Amiodarone, astemizole, bepridil, cisapride, cholestyramine, ergot and ergot derivatives, flecainide, ganciclovir, interferon alfa, midazolam (unless used for sedation on ACTG 723), pimozide, propafenone, propoxyphene, quinidine, ribavirin, rifampin, sucralfate, terfenadine, and triazolam.
  • Rifabutin for patients on RTV in Step 3 and for patients on Steps 1 and 2 because of the contradictory effects of EFV and NFV on plasma rifabutin levels. If a patient on Step 1 or 2 requires treatment with rifabutin after coming on the study, the team must be notified.
  • Alpha tocopherol (vitamin E) supplementation since vitamin E is contained in the soft gelatin capsule formulation of APV.
  • ddI concurrently with IV pentamidine.
  • Herbal medications.]
  • Patients with the following prior conditions are excluded:
  • Pancreatitis within 3 years of study entry.
  • Current peripheral neuropathy grade 2 or greater or history of peripheral neuropathy grade 3 or greater.
  • Documented or suspected acute hepatitis within 30 days prior to study entry.
  • Unexplained temperature above 38.5 C for any 7 days or chronic diarrhea (defined as more than 3 liquid stools per day persisting for more than 15 days) within 30 days prior to study entry.
  • Any previous hypersensitivity to study drugs or their components.
  • Prior Medication:
  • Excluded:
  • Receipt within 30 days of erythropoietin, G-CSF, or GM-CSF.
  • Treatment within 14 days of study entry with any of the following:
  • amiodarone, astemizole, cisapride, ergot or ergot derivatives, ketoconazole, midazolam, propoxyphene, quinidine, rifampin, terfenidine, or triazolam.
  • Prior antiretroviral therapy for 7 days or more, including protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), and nonnucleoside reverse transcriptase inhibitors (NNRTIs). [AS PER AMENDMENT 5/5/99:
  • Systemic ketoconazole or itraconazole, intravenous pentamidine, and rifabutin are prohibited. Midazolam is allowed for sedation in patients participating on ACTG 723.]
  • Any vaccination within 14 days prior to study entry.
  • Any immunomodulator or investigational therapy within 30 days prior to study entry.
  • [AS PER AMENDMENT 5/5/99:
  • 6. Rifabutin is discouraged.]
  • Prior Treatment:
  • Excluded:
  • Acute therapy for an infection or other medical illness within 14 days prior to study entry.
  • [AS PER AMENDMENT 5/5/99:
  • Acute therapy for a serious infection or other serious medical illness that is potentially life-threatening and requires systemic therapy and/or hospitalization within 14 days of study entry. Patients with Pneumocystis carinii pneumonia must have completed acute therapy at least 7 days prior to entry and be clinically stable. Patients with other serious infection or serious medical illness who must continue chronic therapy must have completed at least 14 days of therapy prior to entry and be clinically stable. Patients with all other infections or medical illnesses must have completed therapy, or at least 14 days of maintenance therapy, prior to entry and be clinically stable (restrictions do not apply to oral and vaginal candidiasis, mucocutaneous herpes simplex infection, and minor skin conditions).]
  • Risk Behavior:
  • Excluded:
  • Possible current substance abuse that could prevent compliance with the study medication.

Attachments

readout_NCT00000919_2024-04-16.pdf

4.5 MB

NCT00000919_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

Durham, North Carolina, United States

Cleveland, Ohio, 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

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

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

San Juan, , Puerto Rico

Charlotte, North Carolina, United States

Los Angeles, California, United States

San Francisco, California, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Hershey, Pennsylvania, United States

St Louis, Missouri, United States

Iowa City, Iowa, United States

New Orleans, Louisiana, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

New York, New York, United States

Menlo Park, California, United States

San Rafael, California, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Rochester, New York, United States

Akron, Ohio, United States

Ancona, , Italy

Bologna, , Italy

Brescia, , Italy

Brescia, , Italy

Ferrara, , Italy

Genova, , Italy

Milano, , Italy

Milano, , Italy

Parma, , Italy

Pavia, , Italy

Pavia, , Italy

Reggio Emilia, , Italy

Roma, , Italy

Verona, , Italy

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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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