The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected patients \[AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone versus AZT plus ddI\]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular level. Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.

Key facts

Study ID

NCT00001063

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Expected to finish

1997-11-01

Last updated by the study team

2021-11-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Required for patients whose CD4 count falls below 200 cells/mm3:
• PCP prophylaxis with TMP/SMX, aerosolized pentamidine, or dapsone.
• Allowed:
• Atovaquone, IV pentamidine, trimethoprim-dapsone, clindamycin-primaquine, trimetrexate, or TMP/SMX for acute PCP.
• Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for mucosal and esophageal candidiasis.
• Itraconazole.
• Amphotericin B.
• Rifabutin.
• Isoniazid.
• Pyrazinamide.
• Clofazimine.
• Clarithromycin.
• Azithromycin.
• Ethambutol.
• Amikacin.
• Ciprofloxacin.
• Ofloxacin.
• Pyrimethamine.
• Sulfadiazine.
• Clindamycin.
• Ganciclovir.
• G-CSF.
• Acyclovir (up to 1000 mg/day).
• Erythropoietin.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Malignancy requiring systemic cytotoxic chemotherapy.
• Serious underlying medical condition other than HIV that would reduce life expectancy to < 2 years.
• Concurrent Medication:
• Excluded:
• Antiretrovirals other than study drugs.
• Foscarnet.
• Patients with the following prior conditions are excluded:
• Unexplained temperature >= 38.5 C for 7 days or chronic diarrhea (>= three stools daily) for 15 days, if occurring within 30 days prior to study entry.
• History of acute or chronic pancreatitis.
• History of grade 2 or higher peripheral neuropathy.
• History of grade 3 or worse intolerance to 500-600 mg/day AZT.
• Prior Medication:
• Excluded:
• (within 30 days prior to study entry)
• Prior ddI, ddC, 3TC or d4T (more than 2 weeks total).
• Non-nucleoside reverse transcriptase inhibitor or protease inhibitor.
• Biologic response modifiers such as interferon and IL-2.
• Other experimental therapy.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Weiss Memorial Hosp. — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Tulane Hemophilia Treatment Ctr. — New Orleans, Louisiana, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Washington U CRS — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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