CLINICAL TRIALS
| Clinical Setting | Protocol | Major Entry Criteria | Trial/Drugs |
|---|---|---|---|
| CD4<50 or <100 and a hx of AIDS | GM-CSF Boost Immune Response & To prevent Infections | Karnofsky > 50; No colony stim. factors or cytokines; ANC > 750 platelet > 50,000; Stable antiretrov. | rhu GM-CSF
250 ug or Placebo 2 x/week Duration: +/- 114 days (depends if patient responds to therapy) |
| CD4<200 | Steroid Study | At least 2 months stable antiretroviral therapy; No active fungal or CMV infections | Placebo vx
Prednisone Duration: 2 months |
| CD4<200 | Protease Inhibitor - Indinavir 320 | Greater 3 months ZDV therapy anytime in past; No Acute OI; No acute/chronic pancreatitis; No grade 2 or greater periph. neuropathy; <1 week no 3TC or prot. inhib. ever. No intol. to ZDV 600 | ZDV+3TC+Merck Protease (IDV) OR ZDV+3TC+Merck Protease Placebo
Duration: 48 weeks after last patient entered |
| CD4 200-700 | ACTG 307 Hydroxyurea or Hydroxyurea + ddl | <2 weeks prior ddl; No perifpheral neuropathy greater than or equal to grade 2 | ddl 200 mg bid OR Hydroxyurea OR Hydroxyurea + ddl Duration: 24 weeks |
| Neuropathy | 291 Human Nerve Growth Factor | Patient is competent to assess pain; HIV associated neuropathy (sensory); Dx pain, burning, or dysesthetic discomfort in feet at lease 2 weeks AND either dec. ankle reflexes OR distal diminution of vibratory sense; Stable antiretro or no antiretro for 8 weeks | rhNGF
0.1ug/kg 2X per week OR rhNGF 0.3ug/kg 2X per week OR rhNGF placebo 2X per
week Duration: 18 weeks & open label extension in process |
| Blood Transfusions | Viral Activation via Blood Transfusion | Symptomatic anemia with planned RBC for transfusion that can wait 4 hours; Reason must be non-surgical; CMV sero-positive; Must be first time transfusion; No IV immunoglob. 6 weeks prior; No GCSF/TTP | Leukocyte
Filtered RBC's vs Non-filtered RBC's Duration: 3 years/death/or study termination (whichever comes first) |
| Effects of MAC Tx | 853 | MAC Infection; no use of cytokine inhibitors; no other OI's within 14 days of study entry; no vaccination in last 14 days | Duration: 8 weeks |
| Refractory Oral Candidiasis | rhu GM-CSF & Amphot. B | Oral candid. confirmed via cx; on tx with approved antiretroviral agent for at least one week prior to entering study; pts must have either: received at least 14 consecutive days of fluconazole at 400mg/day or have recurrent oropharyngeal candidiasis following tx with prior IV ampho. B (with no sig. clearing); no other antifungals | Ampho. B
+ GMCSF 2 x/week VS Ampho B Responders will continue GMCSF Duration: 24 weeks |
| Clinical Setting | Protocol | Major Entry Criteria | Trial/Drugs |
|---|---|---|---|
| CMV Neurologic Disease | ACTG 305 | Encephalopathy with at least two of the following: recent memory impairment, delirium, disorient., psychomotor slowing, ataxia, nystagmus, cranial nerve palsy OR Radiculomyelitis: extremity weakness AND either: paresthesia; neural. back pain, perineal pain, bowel or bladder dysfunction, depressed or absent tendon reflexes, sensory loss in S4, S5 dermatomes, weakness of anal sphincter. CSF + for CMV | Induction: Foscarnet 90mg/kg IV q 12h +
ganciclovir 5 mg/kg IV q 12h x 28 days Maintenence: Foscarnet 90 mg/kg IV q 24h and ganciclovir 5 mg/kg IV q 24h x 20 wks * Ganc experienced: will be given GCV at 7.5 mg/kg IV q 12h induction and 10mg/kg IV q 24h maintenence if tolerated Duration: 24 weeks |
| Oro/Esopho. Cand. | Merck-L743,872 | Dx of fluconazole-unresponsive oropharyngeal or esophageal candid.; Normal EKG/Chest Xray. No active OI with acute therapy; no hepatitis or cirrhosis; no rifampin, rifabutin, foscarnet current | L-743,872 OR Ampho.
B Duration: 336 days |
| CD4 > or = 500 | 334 Cyclosporin | Karnofsky greater than or equal to 80; Plasma viral load, greater than 600 copies/ml; No AIDS via CDC criteria; No antiretrovirals or AZT in the past 4 weeks; No autoimmune disease hx; No current antibiotics or antifungals, | Neoral 2mg/kg per day
po OR Neoral 4 mg/kg per day po OR Placebo Duration: 16 weeks |
| CD4 50-300 | ACTG 328 HAART + IL2 | Protease Naive; Must be going to initiate one of the following: ZDV + 3TC; ZDV + ddl, ZDV + 3TC, or d4T + ddl.; No priort IL-2 | ddl/D4T/Indinavir +/- IL-2 Duration: +/- 72 weeks depending on viral load throughout study at set timepoints |
| CD4 > or = 200 | ACTG 349 Prednisone | Must be on at least two approved antiretroviral regimens for at least 12 weeks; Negative TB skin test or if + must have completed at least 6 months of INH therapy | Prednisone Therapy Duration: 14 weeks |
| Viral Load > or = 10,000 CD4 > or = 100 | Glaxo/Wellcome 15U89 + Protease Inhibitor | Never Treated; Any GI Absorption hx; No pancreatitis or hepatitis last 3 years | 1592U89 + Indinavir OR 1592U89 + saquinavir OR 1592U89 +ritonavir OR 1592U89 +nelfinavir OR 1592U89 +141W94 OR 1592U89 +DMP 266 Duration: 48 weeks |
| CD4 > 200 Viral Load > 1000 | ACTG
343 AZT/3TC/Ind | 3TC/Indinavir Naive; Can be AZT experienced | Indinavir, AZT, 3TC Duration: Up to 48 weeks |
| Recurrent Oro-Pharyngeal Candidiasis | ACTG
323 Fluconazole | CD4 | Acute vs Chronic Therapy
with Fluconazole | Duration: Up to 24 months |
Protocols at a Glance: 10 Feb
97
