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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV). Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients often experience unpleasant side effects and have difficulties following the dosing schedule. This study looks for combinations of anti-HIV drugs ("cocktails") which will be the most effective with the fewest problems.

Key facts

Study ID

NCT00000919

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

900

Expected to finish

2002-11-01

Last updated by the study team

2012-06-07

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).]

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
• Marin County Specialty Clinic — San Rafael, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Georgetown Univ Hosp — Washington D.C., District of Columbia, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr — Atlanta, Georgia, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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