Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, imm...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Chemoprophylaxis for Pneumocystis carinii pneumonia.
- • Topical and oral antifungal agents (except for oral ketoconazole and itraconazole).
- • All antibiotics as clinically indicated (unless otherwise excluded).
- • Treatment, maintenance, or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated (unless otherwise excluded).
- • 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, megestrol acetate, testosterone.
- • Alternative therapies such as vitamins. Patients should report the use of these therapies.
- • \[AS PER AMENDMENT 2/16/99: Rifabutin can be administered at a reduced dose.\]
- • \[AS PER AMENDMENT 4/3/00: Systemic cytotoxic chemotherapy. Study team should be notified.\]
- • \[AS PER AMENDMENT 4/3/00: Expanded access and compassionate use drugs are allowed as part of Step 2 treatment only.\]
- Allowed with caution:
- • \[AS PER AMENDMENT 4/3/00: Viagra (sildenafil citrate) at a reduced dose unless otherwise approved by the protocol chair.\]
- • \[AS PER AMENDMENT 4/3/00: Lovastatin or simvastatin with PIs is not recommended. Caution should be exercised with the use of all other statins when used concomitantly with PIs.\]
- Concurrent Treatment:
- Allowed:
- • Alternative therapies such as acupuncture and visualization techniques. Patients should report use of these therapies.
- Patients must have:
- • Documented HIV-1 infection.
- * CD4 count less than or equal to 200 cells/mm3 or a plasma HIV RNA greater than or equal to 100,000 copies/ml \[AS PER AMENDMENT 2/16/99:
- • 80,000 copies/ml\] within 60 days prior to entry.
- • Other lab values performed within 14 days prior to entry.
- Prior Medication:
- Allowed:
- • Zidovudine (ZDV), didanosine (ddI), stavudine (d4T), or zalcitabine (ddC) therapy alone or in combination any time prior to study entry.
- • Exclusion Criteria
- Concurrent Medication:
- Excluded:
- • All antiretroviral therapies other than study medications. \[AS PER AMENDMENT 4/3/00: Compassionate use and expanded access drugs are allowed as part of Step 2 treatment.\]
- • Investigational drugs without specific approval from the Study Chair. \[AS PER AMENDMENT 4/3/00: Compassionate use and expanded access drugs are allowed as part of Step 2 treatment.\]
- • Systemic cytotoxic chemotherapy. \[AS PER AMENDMENT 4/3/00: Systemic cytotoxic chemotherapy is allowed. Study team should be notified.\]
- • Alprazolam, amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, encainide, ergot alkaloids and derivatives of ergot alkaloids, estazolam, flecainide, flurazepam, itraconazole , ketoconazole, meperidine, midazolam, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, rifampin, terfenadine, triazolam, or zolpidem. \[AS PER AMENDMENT 2/16/99: Amiodarone, astemizole, cisapride, ergot alkaloids or drugs containing derivatives of ergot alkaloids, itraconazole, midazolam, triazolam, quinidine, rifampin, terfenadine.\] \[AS PER AMENDMENT 4/3/00: Amiodarone, astemizole, bepridil, cisapride, ergot alkaloids and derivatives of ergot alkaloids, Hypericum perforatum (St. John's wort), itraconazole, midazolam, quinidine, rifampin, terfenadine, triazolam.\]
- • Vitamin E supplements. \[AS PER AMENDMENT 4/3/00: Multivitamins containing vitamin E are allowed.\]
- Avoided:
- • Herbal medications. Patients should report use.
- Patients with the following prior conditions are excluded:
- • Acute therapy for an infection or other medical illnesses within 14 days prior to study entry. \[AS PER AMENDMENT 2/16/99: Acute therapy for a serious infection or other serious medical illnesses that are potentially life-threatening and require systemic therapy and/or hospitalization within 14 days of study entry.\]
- Prior Medication:
- Excluded within 30 days prior to entry:
- • More than 1 day experience with lamivudine (3TC), nonnucleoside reverse transcriptase inhibitor, or protease inhibitor.
- • Erythropoietin, G-CSF, or GM-CSF.
- • Interferons, interleukins, HIV vaccines, or any experimental therapy.
- Excluded within 14 days prior to entry:
- * Alprazolam (Xanax), amiodarone (Cordarone), astemizole (Hismanal), bepridil (Vascor), bupropion (Wellbutrin, Zyban), cisapride (Propulsid), clorazepate (Tranxene), clozapine (Clozaril), diazepam (Valium), encainide (Enkaid), ergot alkaloids or drugs containing derivatives of ergot alkaloids, estazolam (ProSom), flecainide (Tambocor), flurazepam (Dalmane), itraconazole (Sporanox), ketoconazole (Nizoral), meperidine (Demerol), midazolam (Versed), piroxicam (Feldene), propafenone (Rythmol), propoxyphene (Darvon, Darvocet), quinidine, rifabutin (Mycobutin), rifampin (Rifadin, Rifamate, Rifater, Rimactane), terfenadine (Seldane), triazolam (Halcion), or zolpidem (Ambien). \[AS PER AMENDMENT 2/16/99: Agents excluded within 14 days prior to entry are now as follows:
- • amiodarone, astemizole, cisapride, ergot alkaloids or drugs containing derivatives of ergot alkaloids, itraconazole, midazolam, quinidine, rifampin, terfenadine, and triazolam.
- Note:
- • Rifabutin can be administered at a reduced dose of 150 mg/day.\]
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
San Mateo, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Omaha, Nebraska, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
San Juan, , Puerto Rico
St. Louis, Missouri, United States
Chicago, Illinois, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
New York, New York, United States
San Rafael, California, United States
St Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
Patients applied
Trial Officials
Margaret Fischl
Study Chair
Ann Collier
Study Chair
Judith Feinberg
Study Chair
Stefano Vella
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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