The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
Completed · Phase 2
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001067
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 105
- Expected to finish
- 1997-11-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alabama Therapeutics CRS — Birmingham, Alabama, United States
- Stanford CRS — Palo Alto, California, United States
- Ucsd, Avrc Crs — San Diego, California, United States
- Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
- The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
- Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
- Washington U CRS — St Louis, Missouri, United States
- St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
- Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
- NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
- Unc Aids Crs — Chapel Hill, North Carolina, United States
- The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
- Puerto Rico-AIDS CRS — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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