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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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).
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 105

Location and Contact Information:

Overall Study Official:
HavlirD,  Study Chair, 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  921036325
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  277103499
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Univ of Texas Galveston
Galveston,  Texas,  775550435
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Howard Univ
Washington D.C.,  District of Columbia,  20059
United States
 

State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore,  Maryland,  212052196
United States
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

Univ of Puerto Rico
San Juan,  ,  009365067
Puerto Rico
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 

Yale Univ / New Haven
New Haven,  Connecticut,  065102483
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

SUNY / Health Sciences Ctr at Brooklyn
Brooklyn,  New York,  112032098
United States
 


Additional Information:
Study ID Numbers:
  ACTG 298; 
Study Start Date: 
Record last reviewed: December 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001067

Other Hiv Infections Studies:
1. A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection

2. A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood

3. Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo)

4. A Study of Lopinavir/Ritonavir in Infants with HIV

5. The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before

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