Trial Search Results

The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs

To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time.

Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Stanford Investigator(s):

Intervention(s):

  • Drug: Lamivudine
  • Drug: Stavudine
  • Drug: Zidovudine

Phase:

Phase 2

Eligibility


Inclusion Criteria

Concurrent Medication:

Required:

   - TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.

Allowed:

   - Atovaquone.

   - IV pentamidine.

   - TMP / SMX.

   - Trimetrexate.

   - Trimethoprim-dapsone.

   - Clindamycin-primaquine.

   - Topical antifungals.

   - Clotrimazole.

   - Ketoconazole.

   - Fluconazole.

   - Amphotericin B.

   - Itraconazole.

   - Rifabutin.

   - Isoniazid.

   - Pyrazinamide.

   - Clofazimine.

   - Clarithromycin.

   - Azithromycin.

   - Ethambutol.

   - Amikacin.

   - Ciprofloxacin.

   - Ofloxacin.

   - Pyrimethamine.

   - Sulfadiazine.

   - Clindamycin.

   - Filgrastim ( G-CSF ).

   - Up to 1000 mg/day acyclovir.

   - Erythropoietin.

   - Antibiotics.

   - Antipyretics.

   - Analgesics.

   - Antiemetics.

   - Rifampin.

Concurrent Treatment:

Allowed:

   - Local radiation therapy.

Patients must have:

   - HIV infection.

   - CD4 count 300 - 600 cells/mm3.

   - NO history of AIDS.

   - NO active opportunistic infection.

   - NO prior nucleoside therapy.

   - Life expectancy at least 2 years.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

   - Serious underlying medical condition other than HIV such that life expectancy is less
   than 2 years.

   - Malignancy requiring systemic cytotoxic chemotherapy.

   - Active grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

   - Antiretrovirals other than study drugs.

   - Systemic cytotoxic chemotherapy.

   - Foscarnet.

Patients with the following prior conditions are excluded:

   - Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days
   prior to study entry.

   - Unexplained temperature >= 38.5 C for any 7 days within 30 days prior to study entry.

   - Active participation in other experimental therapy within 30 days prior to study
   entry.

Prior Medication:

Excluded:

   - Prior nucleoside antiretrovirals of 1 week or longer duration.

   - Any antiretroviral within 90 days prior to study entry.

   - Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days
   prior to study entry.

   - Biologic response modifiers such as IL-2 and interferon within 30 days prior to study
   entry.

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting