A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience
Lamivudine
+ Stavudine
+ Zidovudine
Infections transmises par le sang+13
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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. Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.105 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 12 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 13 sites
Stanford CRS
Palo Alto, United StatesUcsd, Avrc Crs
San Diego, United StatesHoward University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., United States