Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000903
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
• Scientific title: A Phase III Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination With Fixed-Dose Combination Lamivudine/Zidovudine (3TC/ZDV) and Indinavir (IDV) in HIV-Infected Subjects With Less Than or Equal to 200 CD4 Cells/mm3 or Greater Than or Equal to 80,000 HIV RNA Copies/ml in Plasma
• Date of first enrolment: August 1997
• Target sample size: 444
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000903
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Italy, Puerto Rico, United States

Contacts

• Name: Ann Collier

• Name: Judith Feinberg

• Name: Margaret Fischl

• Name: Stefano Vella

Key inclusion & exclusion 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.]



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Efavirenz

Drug: Indinavir sulfate

Drug: Lamivudine/Zidovudine

Drug: Nelfinavir mesylate

Secondary ID(s)

11347

ACTG 388

Substudy ACTG 732

Substudy ACTG 733

Substudy ACTG 734

Substudy ACTG 735

Substudy ACTG 737

Substudy ACTG 746

Substudy ACTG A5060s

Source(s) of Monetary Support

Please refer to primary and secondary sponsors