The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

Sponsor

Gilead Sciences (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00007436

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase 3

Detailed Description

Patients take tenofovir DF in combination with other antiretrovirals.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay AIDS Ctr	Berkeley	California	United States	94705
2	Tower ID Med Associates	Los Angeles	California	United States	90048
3	Pacific Horizons Med Group	San Francisco	California	United States	94115
4	Harbor - UCLA Med Ctr	Torrance	California	United States	90502
5	Univ of Colorado / Health Science Ctr	Denver	Colorado	United States	80262
6	Physicans Home Service	Washington	District of Columbia	United States	20037
7	Steinhart Medical Associates	Miami	Florida	United States	33133
8	Dr Gerald Pierone Jr	Vero Beach	Florida	United States	32960
9	Northstar Med Clinic	Chicago	Illinois	United States	60657
10	CRI New England	Brookline	Massachusetts	United States	02146
11	Univ of Minnesota	Minneapolis	Minnesota	United States	55455
12	Univ of Rochester Med Ctr	Rochester	New York	United States	14642
13	Research & Education Group	Portland	Oregon	United States	97209
14	Hershey Med Ctr	Hershey	Pennsylvania	United States	17033
15	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15221
16	Roger Williams Med Ctr	Providence	Rhode Island	United States	02908
17	Southwest Infectious Diseases Associates	Dallas	Texas	United States	75246
18	Thomas Street Clinic	Houston	Texas	United States	77009
19	Dr Philip C Craven	Tacoma	Washington	United States	98405