NCT00001010 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Collier AC, Bozzette S, Coombs RW, Causey DM, Schoenfeld DA, Spector SA, Pettinelli CB, Davies G, Richman DD, Leedom JM, et al
A pilot study of low-dose zidovudine in human immunodeficiency virus infection. N Engl J Med. 1990 Oct 11;323(15):1015-21.
Coombs RW, Collier AC, Chaloupka K, Corey L
Decreased HIV plasma titer in response to combined low-dose zidovudine and acyclovir therapy in CDC class IVA patients. Int Conf AIDS. 1990 Jun 20-23;6(1):139 (abstract no ThB24)
ICDB/90665116
Collier A, et al. Virologic and clinical response to combination zidovudine (AZT) and acyclovir (ACV) in AIDS-related complex (ARC). Twenty-ninth Intersci Conf Antimicro Agts and Chemother. 1989 Sep 17-20; 105
Ioannidis JP, Collier AC, Cooper DA, Corey L, Fiddian AP, Gazzard BG, Griffiths PD, Contopoulos-Ioannidis DG, Lau J, Pavia AT, Saag MS, Spruance SL, Youle MS
Clinical efficacy of high-dose acyclovir in patients with human immunodeficiency virus infection: a meta-analysis of randomized individual patient data. J Infect Dis. 1998 Aug;178(2):349-59.
Tartaglione TA, Collier AC, Opheim K, Gianola FG, Benedetti J, Corey L
Pharmacokinetic evaluations of low- and high-dose zidovudine plus high-dose acyclovir in patients with symptomatic human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Nov;35(11):2225-31.

An Uncontrolled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Zidovudine (AZT) and Acyclovir (ACV) Given Concomitantly to Patients With Human Immunodeficiency Virus Infection

Details for clinical trial NCT00001010

Clinical trial NCT00001010 - References