Clinical trial NCT00007436: The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients
Official title: A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents
9-(2-phosphonylmethoxypropyl)adenine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Detailed description: Patients take tenofovir DF in combination with other antiretrovirals.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Have completed another study on tenofovir DF without toxicity.
* Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
* Are taking agents that affect kidney function, such as probenecid.
* Are receiving systemic chemotherapy.
* Are taking systemic corticosteroids.
* Are taking experimental drugs except those that are approved by Gilead.
* Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Los Angeles
country: United States
facility: Tower ID Med Associates
state: California
city: San Francisco
country: United States
facility: Pacific Horizons Med Group
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado / Health Science Ctr
state: Colorado
city: Washington
country: United States
facility: Physicans Home Service
state: District of Columbia
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Vero Beach
country: United States
facility: Dr Gerald Pierone Jr
state: Florida
city: Chicago
country: United States
facility: Northstar Med Clinic
state: Illinois
city: Brookline
country: United States
facility: CRI New England
state: Massachusetts
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Portland
country: United States
facility: Research & Education Group
state: Oregon
city: Hershey
country: United States
facility: Hershey Med Ctr
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Dallas
country: United States
facility: Southwest Infectious Diseases Associates
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: Tacoma
country: United States
facility: Dr Philip C Craven
state: Washington
Study officials:
References: