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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002180 |
Purpose
The purpose of this study is to see if it is safe and effective to give PMPA to HIV-infected patients. This study also examines how the body handles PMPA.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tenofovir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, and Pharmacokinetics, and Antiviral Activity of 9-[(R)-2-(Phosphonomethoxy)Propyl] Adenine (PMPA) in HIV-Infected Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Patients with any of the following prior conditions are excluded:
History of malignancy other than basal cell carcinoma or cutaneous Kaposi's sarcoma.
Patients who are receiving:
Within 2 weeks prior to entry:
Active drug or alcohol abuse as demonstrated by a positive screening test for drugs of abuse (except marijuana or drugs used for medical indications), or substance abuse considered sufficient to hinder patient compliance.
Contacts and Locations| United States, California | |
| San Francisco Gen Hosp / AIDS Program | |
| San Francisco, California, United States, 94110 | |
| United States, Maryland | |
| Johns Hopkins Univ | |
| Baltimore, Maryland, United States, 21205 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002180 History of Changes |
| Other Study ID Numbers: | 269A, GS-96-701 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Placebos Anti-HIV Agents Adenine |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Tenofovir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |