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.
National Institute of Allergy and Infectious Diseases (NIAID)
- Drug: Lamivudine
- Drug: Stavudine
- Drug: Zidovudine
- TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.
- IV pentamidine.
- TMP / SMX.
- Topical antifungals.
- Amphotericin B.
- Filgrastim ( G-CSF ).
- Up to 1000 mg/day acyclovir.
- 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.
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.
- Antiretrovirals other than study drugs.
- Systemic cytotoxic chemotherapy.
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
- 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
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study