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

• Status: Completed
• Trial end date: 1997-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Lamivudine; Stavudine; Zidovudine

Criteria

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.