The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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).
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Palo Alto, California, United States
San Diego, California, United States
Washington, District Of Columbia, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
San Juan, , Puerto Rico
Atlanta, Georgia, United States
Patients applied
Trial Officials
Havlir D
Study Chair
Pollard R
Study Chair
Richman D
Study Chair
Friedland G
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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